General & Plastic Surgery Forceps Suppliers
Limit companies to: Worldwide USA
Fujinon, Inc. | Address: 10 High Point Drive, Wayne, New Jersey 07470, USA 
www.fujinonendoscopy.com | Send Inquiry | Phone: +1-(800)-490-0661
FDA Registration: 2431293 Quality: ISO 9000 Certified
Products: Laryngoscopes, Fiberoptic Bronchoscopes, Articulating Tip Laryngoscopes, Fiber Optic Blade Laryngoscopes, Conventional Laryngoscopes, Fiberoptic Laryngoscopes, ...
Fujinon, Inc. supplies endoscopic equipment. We offer the latest in endoscopic solutions for outpatient facilities, hospitals and teaching institutions. Our most advanced G-5™ endoscopes are now more...
www.fujinonendoscopy.com | Send Inquiry | Phone: +1-(800)-490-0661
FDA Registration: 2431293 Quality: ISO 9000 Certified
Products: Laryngoscopes, Fiberoptic Bronchoscopes, Articulating Tip Laryngoscopes, Fiber Optic Blade Laryngoscopes, Conventional Laryngoscopes, Fiberoptic Laryngoscopes, ...
Fujinon, Inc. supplies endoscopic equipment. We offer the latest in endoscopic solutions for outpatient facilities, hospitals and teaching institutions. Our most advanced G-5™ endoscopes are now more...
Advanced Meditech International, Inc. | Address: 86-38 53rd Avenue, Suite 100, Flushing, New York 11373, USA
www.ameditech.com | Send Inquiry | Phone: +1-(718)-672-7150
FDA Registration: 2436264 Year Established: 1992
Products: Vasectomy Ringed Forceps, Vasectomy Hemostats, Thermal Cautery, Thermal Cautery Electrodes, Surgical Clip Appliers, Surgical Clips, ...
Advanced Meditech International, Inc. focuses on the design, development and marketing of safe medical products. Our product line includes vasectomy products, no-needle medical specialties,thermal cau more...
www.ameditech.com | Send Inquiry | Phone: +1-(718)-672-7150
FDA Registration: 2436264 Year Established: 1992
Products: Vasectomy Ringed Forceps, Vasectomy Hemostats, Thermal Cautery, Thermal Cautery Electrodes, Surgical Clip Appliers, Surgical Clips, ...
Advanced Meditech International, Inc. focuses on the design, development and marketing of safe medical products. Our product line includes vasectomy products, no-needle medical specialties,thermal cau more...
George Tiemann & Co. | Address: 25 Plant Avenue, Hauppauge, New York 11788, USA
www.atozsurgical.com | Send Inquiry | Phone: +1-(631)-273-0005
FDA Registration: 2424531 Annual Revenues: USD 1-5 Million Employee Count: ~20
Products: Blades, Curettes, Forceps (FDA Code: HTD), Scissors, Chalazion Clamps, Army-Navy Retractors, ...
George Tiemann & Co. manufactures surgical instruments. Our products include single patient kit, transplant supplies, ergonomic chair, hair clips, magni-focuser, plastic cups, slot punch, back lightin more...
www.atozsurgical.com | Send Inquiry | Phone: +1-(631)-273-0005
FDA Registration: 2424531 Annual Revenues: USD 1-5 Million Employee Count: ~20
Products: Blades, Curettes, Forceps (FDA Code: HTD), Scissors, Chalazion Clamps, Army-Navy Retractors, ...
George Tiemann & Co. manufactures surgical instruments. Our products include single patient kit, transplant supplies, ergonomic chair, hair clips, magni-focuser, plastic cups, slot punch, back lightin more...
Bausch & Lomb | Address: 1400 N. Goodman St., Rochester, New York 14609, USA
www.bausch.com | Send Inquiry | Phone: +1-(585)-338-6000, 800-553-5340
FDA Registration: 1920664 Annual Revenues: USD 100-500 Million Employee Count: ~1000 Quality: ISO 9000, ISO 9001, ISO 9002, CE Certified
Products: Daily Wear Soft Contact Lenses (FDA Code: LPL), Extended Wear Soft Contact Lenses (FDA Code: LPM), Soft Contact Lense Rinsing Solutions, Soft Contact Lens Storage Solutions, Contact Lens Eye Drops, Soft Contact Lenses For Extended Wear, ...
Bausch & Lomb is the eye health company dedicated to perfecting vision and enhancing life. We offer a comprehensive portfolio of eye health products. Our three broad categories of products are vision more...
www.bausch.com | Send Inquiry | Phone: +1-(585)-338-6000, 800-553-5340
FDA Registration: 1920664 Annual Revenues: USD 100-500 Million Employee Count: ~1000 Quality: ISO 9000, ISO 9001, ISO 9002, CE Certified
Products: Daily Wear Soft Contact Lenses (FDA Code: LPL), Extended Wear Soft Contact Lenses (FDA Code: LPM), Soft Contact Lense Rinsing Solutions, Soft Contact Lens Storage Solutions, Contact Lens Eye Drops, Soft Contact Lenses For Extended Wear, ...
Bausch & Lomb is the eye health company dedicated to perfecting vision and enhancing life. We offer a comprehensive portfolio of eye health products. Our three broad categories of products are vision more...
Accurate Surgical & Scientific Instruments Corporation | Address: 300 Shames Drive, Westbury, New York 11590, USA
www.accuratesurgical.com | Send Inquiry | Phone: +1-(516)-333-5270
FDA Registration: 2434839
Products: Microinstruments, Stevens Tenotomy Scissors, General Surgical Instruments, Single Use Surgical Instruments, Neurology Instruments, Surgical Instrument (Miscellaneous Medical), ...
Accurate Surgical & Scientific Instruments Corporation specializes in surgical instruments for microsurgery, hand, plastic, reconstructive, ophthalmology, neurosurgery, urology & infertility, ENT and more...
www.accuratesurgical.com | Send Inquiry | Phone: +1-(516)-333-5270
FDA Registration: 2434839
Products: Microinstruments, Stevens Tenotomy Scissors, General Surgical Instruments, Single Use Surgical Instruments, Neurology Instruments, Surgical Instrument (Miscellaneous Medical), ...
Accurate Surgical & Scientific Instruments Corporation specializes in surgical instruments for microsurgery, hand, plastic, reconstructive, ophthalmology, neurosurgery, urology & infertility, ENT and more...
Teleflex Medical | Address: PO Box 12600, Research Triangle Park, North Carolina 27709, USA
www.teleflexmedical.com | Send Inquiry | Phone: +1-(919)-544-8000
FDA Registration: 1044475 Annual Revenues: USD 50-100 Million Employee Count: ~380 Quality: ISO 9001, CE Certified
Products: Absorbable Sutures (FDA Code: GAK), General Diagnostic Supplies, General Medical Supplies, General Sutures/Needles, Non-Absorbable Sutures (FDA Code: GAO), Suture Needles, ...
Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical more...
www.teleflexmedical.com | Send Inquiry | Phone: +1-(919)-544-8000
FDA Registration: 1044475 Annual Revenues: USD 50-100 Million Employee Count: ~380 Quality: ISO 9001, CE Certified
Products: Absorbable Sutures (FDA Code: GAK), General Diagnostic Supplies, General Medical Supplies, General Sutures/Needles, Non-Absorbable Sutures (FDA Code: GAO), Suture Needles, ...
Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical more...
Ethicon Endo-Surgery, Inc. | Address: 4545 Creek Road, Cincinnati, Ohio 45242-2839, USA
www.ethiconendo.com | Send Inquiry | Phone: +1-(513)-337-8901, (800)-873-3636
FDA Registration: 3005075853 Annual Revenues: USD 1-5 Million Employee Count: ~3000 Quality: CE Certified
Products: Clamps, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Procedure Trays, Retractors, Powered Surgical Laser Instrument (FDA Code: GEX), ...
Ethicon Endo-Surgery, Inc. produces & markets advanced medical devices for minimally invasive and open surgical procedures. We offer products like brest care products, surgical stapling products, ener more...
www.ethiconendo.com | Send Inquiry | Phone: +1-(513)-337-8901, (800)-873-3636
FDA Registration: 3005075853 Annual Revenues: USD 1-5 Million Employee Count: ~3000 Quality: CE Certified
Products: Clamps, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Procedure Trays, Retractors, Powered Surgical Laser Instrument (FDA Code: GEX), ...
Ethicon Endo-Surgery, Inc. produces & markets advanced medical devices for minimally invasive and open surgical procedures. We offer products like brest care products, surgical stapling products, ener more...
Cardinal Health, Inc. | Address: 7000 Cardinal Place, Dublin, Ohio 43017, USA
www.cardinal.com | Phone: +1-(614)-757-5000, 800-234-8701
Products: Heat or Cold Packs, General Bandages, Infusion Pumps, Ambulatory Pumps, IV Infusion Systems, Surgical Drapes (FDA Code: KKX), Electronic Thermometer, ...
Cardinal Health is a manufacturer and distributor of medical & surgical supplies. Our clinical and medical products segment manufactures medication infusion & dispensing products, respiratory equipmen more...
www.cardinal.com | Phone: +1-(614)-757-5000, 800-234-8701
Products: Heat or Cold Packs, General Bandages, Infusion Pumps, Ambulatory Pumps, IV Infusion Systems, Surgical Drapes (FDA Code: KKX), Electronic Thermometer, ...
Cardinal Health is a manufacturer and distributor of medical & surgical supplies. Our clinical and medical products segment manufactures medication infusion & dispensing products, respiratory equipmen more...
Conmed Integrated Systems | Address: 1815 NW 169th Place, Suite 4020, Beaverton, Oregon 97006, USA
www.conmed.com/IntegratedSystems_newdesign.php | Send Inquiry | Phone: +1-(503)-614-1106
Products: Integrated OR Systems, Arthroscopy Instruments, Electrosurgery, Endoscopy Devices, Patient Care Suction Apparatus (FDA Code: DWM), Integrated Diagnostic Systems, ...
Conmed Integrated Systems provides technology and service for the medical environment. We design completely integrated surgical suites and other patient critical care environments. We offer products l more...
www.conmed.com/IntegratedSystems_newdesign.php | Send Inquiry | Phone: +1-(503)-614-1106
Products: Integrated OR Systems, Arthroscopy Instruments, Electrosurgery, Endoscopy Devices, Patient Care Suction Apparatus (FDA Code: DWM), Integrated Diagnostic Systems, ...
Conmed Integrated Systems provides technology and service for the medical environment. We design completely integrated surgical suites and other patient critical care environments. We offer products l more...
Aesculap Inc. | Address: 3773 Corporate Parkway, Center Valley, Pennsylvania 18034, USA
www.aesculapusa.com | Send Inquiry | Phone: +1-(800)-258-1946
FDA Registration: 2916714 Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~120
Products: Curettes, Drills, Titanium Plating Systems, Suction Tubes, Dural Substitute, Posterior, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou more...
www.aesculapusa.com | Send Inquiry | Phone: +1-(800)-258-1946
FDA Registration: 2916714 Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~120
Products: Curettes, Drills, Titanium Plating Systems, Suction Tubes, Dural Substitute, Posterior, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou more...
Small Bone Innovations, Inc | Address: 1380 S. Pennsylvania Avenue, Morrisville, Pennsylvania 19067, USA
www.totalsmallbone.com | Phone: +1-(215)-428-1791
Products: CMC and IP Joint Implants, Biaxial Total Wrist Arthroplasty, Carpal Fusion Plate, Dorsal Distal Radius Plate, Elbow Implant, Proximal Radial Head Prosthesis, Elbow Implant, Recon Prosthesis, ...
Small Bone Innovations, Inc. delivers arthroplasty, fixation, trauma and biologic solutions. Our Head™ proximal radial head is designed to anatomically articulate with the convexity of the capit more...
www.totalsmallbone.com | Phone: +1-(215)-428-1791
Products: CMC and IP Joint Implants, Biaxial Total Wrist Arthroplasty, Carpal Fusion Plate, Dorsal Distal Radius Plate, Elbow Implant, Proximal Radial Head Prosthesis, Elbow Implant, Recon Prosthesis, ...
Small Bone Innovations, Inc. delivers arthroplasty, fixation, trauma and biologic solutions. Our Head™ proximal radial head is designed to anatomically articulate with the convexity of the capit more...
Sklar Instruments | Address: 889 S. Matlack St, West Chester, Pennsylvania 19382, USA
www.sklarcorp.com | Send Inquiry | Phone: +1-(610)-430-3200, 800-221-2166
FDA Registration: 2431166
Products: Alligator Forceps, Adult Stethoscope, Aneroid Sphygmomanometer, Aortic Aneurysm Clamps, Anastomosis Clamps, Adult Laryngoscope Lamp, ...
Sklar Instruments supplies surgical instruments. Our product categories are arthroscopy, dental, dermal, diagnostic, electrosurgery, genitourinary, and orthodontics. Our Sklar Tite™ line of seal more...
www.sklarcorp.com | Send Inquiry | Phone: +1-(610)-430-3200, 800-221-2166
FDA Registration: 2431166
Products: Alligator Forceps, Adult Stethoscope, Aneroid Sphygmomanometer, Aortic Aneurysm Clamps, Anastomosis Clamps, Adult Laryngoscope Lamp, ...
Sklar Instruments supplies surgical instruments. Our product categories are arthroscopy, dental, dermal, diagnostic, electrosurgery, genitourinary, and orthodontics. Our Sklar Tite™ line of seal more...
North Safety Products U.S.A. | Address: 2000 Plainfield Pike, Cranston, Rhode Island 02921, USA
www.northsafety.com | Send Inquiry | Phone: +1-(401)-943-4400, 800-430-4110
Year Established: 1973 Annual Revenues: USD 5-10 Million Quality: ISO 9001 Certified
Products: Ear & Hearing Protection, General Ophthalmics Supplies, OSHA Compliant, Hearing Protection Kits, Hearing Protection Kits, Ear Production, Personal Ear Plugs, Ear Plug, ...
North Safety Products U.S.A. specializes in protective products. Our product catalog comprises of respiratory protection, head protection, hearing protection, eye & face protection, fall protection an more...
www.northsafety.com | Send Inquiry | Phone: +1-(401)-943-4400, 800-430-4110
Year Established: 1973 Annual Revenues: USD 5-10 Million Quality: ISO 9001 Certified
Products: Ear & Hearing Protection, General Ophthalmics Supplies, OSHA Compliant, Hearing Protection Kits, Hearing Protection Kits, Ear Production, Personal Ear Plugs, Ear Plug, ...
North Safety Products U.S.A. specializes in protective products. Our product catalog comprises of respiratory protection, head protection, hearing protection, eye & face protection, fall protection an more...
Smith & Nephew Inc. | Address: 1450 Brooks Road, Memphis, Tennessee 38116, USA
www.smith-nephew.com | Phone: +1-(901)-399-2121, 800-821-5700
Annual Revenues: USD 50-100 Million Employee Count: ~400 Quality: ISO 9001 Certified
Products: Middle Ear Implants, ENT Implants, Ventilation Tubes, AC-Powered Operating Room Table (FDA Code: FQO), AC-Powered Surgical Instrument Motor (FDA Code: GEY), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Abdominal Trocar, ...
Smith & Nephew is a wound care management company that manufactures and supplies medical products for the diagnosis of wound care management. Our products & services for wound, skin, IV, & burn care i more...
www.smith-nephew.com | Phone: +1-(901)-399-2121, 800-821-5700
Annual Revenues: USD 50-100 Million Employee Count: ~400 Quality: ISO 9001 Certified
Products: Middle Ear Implants, ENT Implants, Ventilation Tubes, AC-Powered Operating Room Table (FDA Code: FQO), AC-Powered Surgical Instrument Motor (FDA Code: GEY), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Abdominal Trocar, ...
Smith & Nephew is a wound care management company that manufactures and supplies medical products for the diagnosis of wound care management. Our products & services for wound, skin, IV, & burn care i more...
DeRoyal Industries | Address: 200 DeBusk Lane, Powell, Tennessee 37849, USA
www.deroyal.com | Send Inquiry | Phone: +1-(800)-251-9864
FDA Registration: 1048770 Year Established: 1976 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO Certified
Products: Splints, Autoclaves, Procedure Trays, Retractors, Esophageal Stethoscopes (FDA Code: BZW), Aspirators, ...
DeRoyal Industries manufactures healthcare products. Our product ranges from orthopedic hospital brands to online tools that power the medical industry. Our night splint is available with adjustable s more...
www.deroyal.com | Send Inquiry | Phone: +1-(800)-251-9864
FDA Registration: 1048770 Year Established: 1976 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO Certified
Products: Splints, Autoclaves, Procedure Trays, Retractors, Esophageal Stethoscopes (FDA Code: BZW), Aspirators, ...
DeRoyal Industries manufactures healthcare products. Our product ranges from orthopedic hospital brands to online tools that power the medical industry. Our night splint is available with adjustable s more...
Microsurgery Instruments, Inc. | Address: P.O. BOX 1378, Bellaire, Texas 77402, USA
www.microsurgeryusa.com | Send Inquiry | Phone: +1-(713)-664-4707
FDA Registration: 1645452
Products: Surgical Loupes, Light Sources Advanced Light Source, Light Sources White Light Source, Light Sources Creative Light Source, Light Sources Alternative Light Source, Surgical Lighting, ...
Microsurgery Instruments, Inc. specializes in microsurgery and other delicate surgical products. We focus on orthopedics, cardiovascular, plastic surgery, hand surgery, urology, surgical loupes, needl more...
www.microsurgeryusa.com | Send Inquiry | Phone: +1-(713)-664-4707
FDA Registration: 1645452
Products: Surgical Loupes, Light Sources Advanced Light Source, Light Sources White Light Source, Light Sources Creative Light Source, Light Sources Alternative Light Source, Surgical Lighting, ...
Microsurgery Instruments, Inc. specializes in microsurgery and other delicate surgical products. We focus on orthopedics, cardiovascular, plastic surgery, hand surgery, urology, surgical loupes, needl more...
Boss Instruments, Ltd. | Address: 395 Reas Ford Road, Suite 120, Earlysville, Virginia 22936, USA
www.bossinst.com | Send Inquiry | Phone: +1-(800)-210-2677
FDA Registration: 1056350 Year Established: 1990 Annual Revenues: < USD 1 Million Employee Count: ~10 Quality: ISO 9000, ISO 9002, CE Certified
Products: Tissue Forceps, Sinus Trochars and Cannulae, Tourniquets, Vascular Clamps (FDA Code: DXC), Adjustable Bone Holding Forceps, Dilators, ...
Boss Instruments, Ltd. is a surgical instrument company which concentrates on the manufacture and continual development of specialty lines of instruments include ear, nose, and throat, general surgery more...
www.bossinst.com | Send Inquiry | Phone: +1-(800)-210-2677
FDA Registration: 1056350 Year Established: 1990 Annual Revenues: < USD 1 Million Employee Count: ~10 Quality: ISO 9000, ISO 9002, CE Certified
Products: Tissue Forceps, Sinus Trochars and Cannulae, Tourniquets, Vascular Clamps (FDA Code: DXC), Adjustable Bone Holding Forceps, Dilators, ...
Boss Instruments, Ltd. is a surgical instrument company which concentrates on the manufacture and continual development of specialty lines of instruments include ear, nose, and throat, general surgery more...
EBI Patient Care, Inc. | Address: 1 Electro-biology Blvd., Guaynabo 00657, USA
Phone: +1-(973)-299-9300
FDA Registration: 3003435252
Products: Bone Taps (FDA Code: HWX), Arm Slings (FDA Code: ILI), Abdominal Binders (FDA Code: FSD), Bone Fixation Plate (FDA Code: HRS), Bone Fixation Screw (FDA Code: HWC), Cast Bandage (FDA Code: ITG), ...
EBI Patient Care, Inc. provides braces thermal therapy devices, spinal endoscopic system and cast bandage. more...
Phone: +1-(973)-299-9300
FDA Registration: 3003435252
Products: Bone Taps (FDA Code: HWX), Arm Slings (FDA Code: ILI), Abdominal Binders (FDA Code: FSD), Bone Fixation Plate (FDA Code: HRS), Bone Fixation Screw (FDA Code: HWC), Cast Bandage (FDA Code: ITG), ...
EBI Patient Care, Inc. provides braces thermal therapy devices, spinal endoscopic system and cast bandage. more...
Joimax, Inc. | Address: 275 E. Hacienda Avenue, Campbell, California 95008, USA
www.joimaxusa.com | Send Inquiry | Phone: +1-(408)-370-3005
FDA Registration: 3005042595
Products: Light Sources, Electrosurgical Systems, Irrigation Pumps, Disposable Surgical Instrument Kit (FDA Code: KDD), Endoscopic Surgical Light (FDA Code: FSW), Endoscopic Electrosurgical Unit and Accessories (FDA Code: KNS), ...
Joimax, Inc. deals with endoscopic spinal surgery. We offer Tessys®, video twister™, C-camsource®, jIFP 2000™, Surgimax™ and JFM 1910™. Our Tessys® spinal stenosis more...
www.joimaxusa.com | Send Inquiry | Phone: +1-(408)-370-3005
FDA Registration: 3005042595
Products: Light Sources, Electrosurgical Systems, Irrigation Pumps, Disposable Surgical Instrument Kit (FDA Code: KDD), Endoscopic Surgical Light (FDA Code: FSW), Endoscopic Electrosurgical Unit and Accessories (FDA Code: KNS), ...
Joimax, Inc. deals with endoscopic spinal surgery. We offer Tessys®, video twister™, C-camsource®, jIFP 2000™, Surgimax™ and JFM 1910™. Our Tessys® spinal stenosis more...
Tab Surgical Instruments, Inc. | Address: 371 E. Street, Chula Vista, California 91910, USA
Phone: +1-(619)-4221348
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Scalpel Blade (FDA Code: GES), General Surgical Scissors (FDA Code: LRW), Manual Osteotome (FDA Code: GFI), Manual Surgical Chisel (FDA Code: FZO), ...
Tab Surgical Instruments, Inc. specializes in the production of surgical products. Our product line comprises of caliper, curette, ENT speculum holder, needle holder, forceps, cannula, spatula, surgic more...
Phone: +1-(619)-4221348
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Scalpel Blade (FDA Code: GES), General Surgical Scissors (FDA Code: LRW), Manual Osteotome (FDA Code: GFI), Manual Surgical Chisel (FDA Code: FZO), ...
Tab Surgical Instruments, Inc. specializes in the production of surgical products. Our product line comprises of caliper, curette, ENT speculum holder, needle holder, forceps, cannula, spatula, surgic more...
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FDA Code / Regulation: GEN / 878.4800
A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 878.9.
