Surgistar Inc.

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Web: http://www.surgistar.com
E-Mail:
Address: 820 Corridor Park Blvd, Knoxville, Tennessee 37932, USA
Phone: +1-(865)-671-4300 | Fax: +1-(865)--671-4302 | Map/Directions >>
 
 

Profile: Surgistar, Inc. is a manufacturer of single use ophthalmic, ENT and surgical products. Our ophthalmology products include knives, blades, cannulas, microkeratome blades, tubing, and corneal trephines. Our ENT products includes curette, flat stock knives & blades, and round stock knives & blades. Our medical & surgical products include cardiovascular, dermatology, arthoscopic, hair transplant, podiatry, and handles.

The company was founded in 1992, has revenues of USD 5-10 Million, has ~40 employees and is ISO 9001 certified.

FDA Registration Number: 2028661

37 Products/Services (Click for related suppliers)  
• AC-Powered Keratome (FDA Code: HNO / 886.4370)
A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.
• Anterior Chamber Maintainers
• Arthroscopic Equipment
• Blades and Knives, Tunnel Blades
• Cannulas
• Cardiovascular Equipment Kits
• Cardiovascular Trocar (FDA Code: DRC / 870.1390)
A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.
• Choppers
• Corneal Trephines
• Cystotome (FDA Code: HNY / 886.4350)
A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.
• Cystotome Needles
• Dermatology Equipment
• Disposable Aspiration and Injection Needle (FDA Code: GAA / 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.
• Disposable Surgical Instrument (FDA Code: KDC / 878.4800)
• ENT Trocar (FDA Code: KTE / 874.4420)
• Eye Knife Test Drum (FDA Code: HMS / 886.4230)
An ophthalmic knife test drum is a device intended to test the keenness of ophthalmic surgical knives to determine whether resharpening is needed.
• Gastro-Urology Trocar (FDA Code: FBQ / 876.5090)
A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.
• General & Plastic Surgery Laparoscope (FDA Code: GCJ / 876.1500)
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
• Hydrodissectors
• Laparoscopic Equipment
• Laryngeal Trocar (FDA Code: KAB / 874.4420)
• Microkeratome Blades
• Microkeratomes
• MVR Blades
• Neck Supplies
• Non-Disposable Suprapubic Trocar and Cannula (FDA Code: FBM / 876.5090)
• One-Piece Scalpel (FDA Code: GDX / 878.4800)
• Ophthalmic Aspiration Cannula (FDA Code: HMX / 886.4350)
• Ophthalmic Cannula (FDA Code: HMX / 886.4350)
• Ophthalmic Knife (FDA Code: HNN / 886.4350)
• Orthopedic Devices
• Sickle Blades
• Sinus Trocar (FDA Code: KBG / 874.4420)
• Surgical Ophthalmic Cannula (FDA Code: HMX / 886.4350)
• Trabeculectomy Blades
• Tracheal Trocar (FDA Code: KCI / 874.4420)
• Trocars

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