Profile: Kirwan Surgical Products manufactures surgical instruments for microsurgical specialties such as neurosurgery, ophthalmology & ear, nose and throat. Our Aura™ line of non-stick forceps offers a variety of forcep styles. Our Aura™ non-stick forceps employs a patented metal formulation that creates an extremely conductive pathway for the electrons. We also provide bipolar & monopolar instruments, cords and I/A handpieces. Our bipolar instruments include cushing, Gerald, hardy, lightweight, and yasargil bayonet.

The company was founded in 1979, has ~180 employees and is ISO 9001, CE certified.

FDA Registration Number: 1219619

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• AC-Powered Thermal Cautery Unit (FDA Code: HQO / 886.4115) A thermal cautery unit is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by heat conducted through a wire tip.

• Adson 1 x 2 Teeth Tissue Forceps

• Adson Tissue Forceps

• Adson-Graefe Tissue Forceps

• Aneurysm Clip (FDA Code: HCH / 882.5200) An aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent it from bleeding or bursting.

• Aspiration Handpieces

• Atraumatic Tissue Forceps

• Awl (FDA Code: HWJ / 888.4540) An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

• Bankart Shoulder Repair Set

• Battery-Powered Thermal Cautery Unit (FDA Code: HQP / 886.4115)

• Bipolar Coagulator System

• Bipolar Cords

• Bipolar Electrosurgical Forceps

• Bipolar Endoscopic Coagulator-Cutter and Accessories (FDA Code: HIN / 884.4150) A bipolar endoscopic coagulator-cutter is a device used to perform female sterilization and other operative procedures under endoscopic observation. It destroys tissue with high temperatures by directing a high frequency electrical current through tissue between two electrical contacts of a probe. This generic type of device may include the following accessories: an electrical generator, probes, and electrical cables.

• Bipolar Forceps

• Bipolar Forceps, Handswitching

• Bipolar Instruments

• Bipolar Irrigating Coagulator

• Bipolar Suction Coagulator

• Bone Mallet Solid Stainless Head

• Bone Mallets (FDA Code: HXL / 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.

• Bone Rasps (FDA Code: HTR / 878.4800)

• Bone Skid (FDA Code: HWO / 888.4540)

• Cable Electrosurgical Unit Adapter

• Carotid Artery Clamp (FDA Code: HCE / 882.5175) A carotid artery clamp is a device that is surgically placed around a patient's carotid artery (the principal artery in the neck that supplies blood to the brain) and has a removable adjusting mechanism that protrudes through the skin of the patient's neck. The clamp is used to occlude the patient's carotid artery to treat intracranial aneurysms (balloonlike sacs formed on blood vessels) or other intracranial vascular malformations that are difficult to attach directly by reducing the blood pressure and blood flow to the aneurysm or malformation.

• Cosmetic Microsurgical Instruments

• Cosmetic Surgery, Dressing Forceps

• Cranial Drill

• Cushing Dressing Forceps

• Delicate Tissue Forceps

• Disposable Aspiration and Injection Needle (FDA Code: GAA / 878.4800)

• Disposable Biopsy Forceps

• Disposable Injectable Monopolar Needle Electrodes

• Dressing and Tissue Forceps

• Dressing Forceps

• Ear & Nasal Dressing Forceps

• Ear Dressing Forceps

• Electrosurgery, Dressing Forceps

• Electrosurgery, Tissue Forceps

• Electrosurgical Apparatus (FDA Code: HAM / 878.4400) An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

• Electrosurgical Cutting and Coagulation Device (FDA Code: GEI / 878.4400)

• Electrosurgical Electrode (FDA Code: JOS / 878.4400)

• Electrosurgical Forceps

• Electrosurgical Unit Cable

• Endoscope Electric Cord (FDA Code: FFZ / 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.

• Endoscopic Forceps

• Eye Dressing Forceps

• Forceps (FDA Code: HTD / 878.4800)

• General & Plastic Saw Surgical Blade (FDA Code: GFA / 878.4820) Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

• General & Plastic Surgery Forceps (FDA Code: GEN / 878.4800)