Sinus Cannula Suppliers
Limit companies to: Worldwide USA
Medtronic Xomed Surgical Products, Inc | Address: 6743 Southpoint Drive North, Jacksonville, Florida 32216-0980, USA 
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Sinus Trochars and Cannulae, Surgical Navigation Interface/Display, Nerve Stimulators, Eyeshields, General Diagnostic Supplies, General Surgical Aids, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Sinus Trochars and Cannulae, Surgical Navigation Interface/Display, Nerve Stimulators, Eyeshields, General Diagnostic Supplies, General Surgical Aids, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
KLS Martin, L.P. | Address: 11239-1 St.Johns Industrial Parkway S, Jacksonville, Florida 32246-7652, USA
www.klsmartinusa.com | Send Inquiry | Phone: +1-(904)-641-7746, 800-625-1557
FDA Registration: 1057946 Year Established: 1993 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9001 Certified
Products: Elevators, Instruments, Castroviejo Calipers, Neurological Instruments, Pituitary Scoops, Cervical Spine Retractor System, Hand Held Instruments, Periosteals Elevators, ...
KLS Martin, L.P. focuses on surgical fields. Our mario® instrument management software manages & controls sterile supplies according to economic, technical & process-oriented criteria. Our C-plate more...
www.klsmartinusa.com | Send Inquiry | Phone: +1-(904)-641-7746, 800-625-1557
FDA Registration: 1057946 Year Established: 1993 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9001 Certified
Products: Elevators, Instruments, Castroviejo Calipers, Neurological Instruments, Pituitary Scoops, Cervical Spine Retractor System, Hand Held Instruments, Periosteals Elevators, ...
KLS Martin, L.P. focuses on surgical fields. Our mario® instrument management software manages & controls sterile supplies according to economic, technical & process-oriented criteria. Our C-plate more...
Luxtec | Address: 99 Hartwell Street, West Boylston, Maryland 01583, USA
www.luxtec.com | Send Inquiry | Phone: +1-(508)-835-9700
Year Established: 1981 Annual Revenues: USD 10-25 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Light Sources, Surgical Headlights, Recording Systems, Headlight Box / Light source, Digital Video Recorders, Recording Devices, ...
Luxtec produces medical illumination systems. We develop lighting and visualization systems for the operating room. Our products include headlights, ultralite, halogen, camera, surgical loupes, monito more...
www.luxtec.com | Send Inquiry | Phone: +1-(508)-835-9700
Year Established: 1981 Annual Revenues: USD 10-25 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Light Sources, Surgical Headlights, Recording Systems, Headlight Box / Light source, Digital Video Recorders, Recording Devices, ...
Luxtec produces medical illumination systems. We develop lighting and visualization systems for the operating room. Our products include headlights, ultralite, halogen, camera, surgical loupes, monito more...
Stryker | Address: 2825 Airview Boulevard, Kalamazoo, Michigan 49002, USA
www.stryker.com/en-us/index.htm | Phone: +1-(269)-385-2600
Products: Saws (FDA Code: HSO), Titanium Plating Systems, Resorbable Plating Systems, Fracture Hardware, Cannulated Screws, Pelvic Plating Systems, ...
Stryker offers a full range of laparoscopic products that meet the performance needed by surgeons. From the uniform image created by our laparoscopes to our StrykeFlow II suction irrigation system, we more...
www.stryker.com/en-us/index.htm | Phone: +1-(269)-385-2600
Products: Saws (FDA Code: HSO), Titanium Plating Systems, Resorbable Plating Systems, Fracture Hardware, Cannulated Screws, Pelvic Plating Systems, ...
Stryker offers a full range of laparoscopic products that meet the performance needed by surgeons. From the uniform image created by our laparoscopes to our StrykeFlow II suction irrigation system, we more...
Jedmed Instrument Company | Address: 5416 JEDMED Court, St. Louis, Missouri 63129-2221, USA
www.jedmed.com | Send Inquiry | Phone: +1-(314)-845-3770
FDA Registration: 1926681 Annual Revenues: < USD 1 Million Employee Count: ~40 Quality: ISO Certified
Products: Dry Heat Sterilizers (FDA Code: KMH), Laboratory Sterilizers, Endoscopes, Laboratory Steam Sterilizers, Benchtop Steam Sterilizers, Endoscopes, Stabilization and Steering, ...
Jedmed Instrument Company manufactures instruments in the areas of ENT, opthalmology and dentistry. Our endonasal DCR technique uses a fiberoptic probe inserted in the punctum for guidance. Our kaps t more...
www.jedmed.com | Send Inquiry | Phone: +1-(314)-845-3770
FDA Registration: 1926681 Annual Revenues: < USD 1 Million Employee Count: ~40 Quality: ISO Certified
Products: Dry Heat Sterilizers (FDA Code: KMH), Laboratory Sterilizers, Endoscopes, Laboratory Steam Sterilizers, Benchtop Steam Sterilizers, Endoscopes, Stabilization and Steering, ...
Jedmed Instrument Company manufactures instruments in the areas of ENT, opthalmology and dentistry. Our endonasal DCR technique uses a fiberoptic probe inserted in the punctum for guidance. Our kaps t 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...
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...
Miltex, Inc. | Address: 589 Davies Drive, York, Pennsylvania 17402, USA
www.miltex.com | Send Inquiry | Phone: +1-(717)-840-9335
FDA Registration: 2523190 Year Established: 1950 Employee Count: ~200 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Scissors, Vasectomy Ringed Forceps, Vasectomy Hemostats, General Medical Supplies, General Surgical Instruments, ...
Miltex, Inc. specializes in surgical and dental instruments. Our product line includes surgical, dental, gynecology, animal health, podiatry and repair instruments. Our Miltex® endometrial samplin more...
www.miltex.com | Send Inquiry | Phone: +1-(717)-840-9335
FDA Registration: 2523190 Year Established: 1950 Employee Count: ~200 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Scissors, Vasectomy Ringed Forceps, Vasectomy Hemostats, General Medical Supplies, General Surgical Instruments, ...
Miltex, Inc. specializes in surgical and dental instruments. Our product line includes surgical, dental, gynecology, animal health, podiatry and repair instruments. Our Miltex® endometrial samplin more...
Helix Medical, LLC | Address: 1110 Mark Avenue, Carpinteria, California 93013-2918, USA
www.helixmed.com | Send Inquiry | Phone: +1-(805)-684-3304, 800-266-4421
FDA Registration: 2025182 Year Established: 1984 Annual Revenues: USD 10-25 Million Employee Count: ~150 Quality: ISO 13485 Certified
Products: Braid/Coil Reinforced Tubing, Braided Tubing, Custom Molding, Custom Extrusions, Color Stripe Tubings, Close Tolerance Tubings, ...
Helix Medical, LLC is a supplier of biocompatible silicone medical devices and components to the medical device, pharmaceutical & biotech industries. We specialize in tubings, stoppers and gaskets. Ou more...
www.helixmed.com | Send Inquiry | Phone: +1-(805)-684-3304, 800-266-4421
FDA Registration: 2025182 Year Established: 1984 Annual Revenues: USD 10-25 Million Employee Count: ~150 Quality: ISO 13485 Certified
Products: Braid/Coil Reinforced Tubing, Braided Tubing, Custom Molding, Custom Extrusions, Color Stripe Tubings, Close Tolerance Tubings, ...
Helix Medical, LLC is a supplier of biocompatible silicone medical devices and components to the medical device, pharmaceutical & biotech industries. We specialize in tubings, stoppers and gaskets. Ou more...
Acclarent, Inc. | Address: 1525-B O'Brien Dr., Menlo Park, California 94025, USA
www.acclarent.com | Send Inquiry | Phone: +1-(650)-687-5888, 877-775-2789
FDA Registration: 3005172759 Year Established: 2004
Products: Balloon Inflation Devices, Bronchoscope Accessories (FDA Code: KTI), ENT Manual Surgical Instrument (FDA Code: LRC), Flexible/Rigid Nasopharyngoscope (FDA Code: EOB), Sinus Cannula (FDA Code: KAM), Iontophoresis Device (FDA Code: EGJ), ...
Acclarent, Inc. focuses on sinus surgery with endoscopic, catheter-based tools; namely Balloon Sinuplasty™ devices. The Balloon Sinuplasty™ system enables otolaryngologists to dilate obstr more...
www.acclarent.com | Send Inquiry | Phone: +1-(650)-687-5888, 877-775-2789
FDA Registration: 3005172759 Year Established: 2004
Products: Balloon Inflation Devices, Bronchoscope Accessories (FDA Code: KTI), ENT Manual Surgical Instrument (FDA Code: LRC), Flexible/Rigid Nasopharyngoscope (FDA Code: EOB), Sinus Cannula (FDA Code: KAM), Iontophoresis Device (FDA Code: EGJ), ...
Acclarent, Inc. focuses on sinus surgery with endoscopic, catheter-based tools; namely Balloon Sinuplasty™ devices. The Balloon Sinuplasty™ system enables otolaryngologists to dilate obstr more...
R Medical Inc. | Address: 28835 N. Herky Drive, Unit 101, Lake Bluff, Illinois 60044, USA
r-medicalinc.com | Send Inquiry | Phone: +1-(847)-816 1615
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
R Medical Inc. provides instruments & equipment for both open surgery & for endoscopy. We specialize in Easy-port® trocars, the Rudolf laparoscopy system instruments with cameras and light sources more...
r-medicalinc.com | Send Inquiry | Phone: +1-(847)-816 1615
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
R Medical Inc. provides instruments & equipment for both open surgery & for endoscopy. We specialize in Easy-port® trocars, the Rudolf laparoscopy system instruments with cameras and light sources more...
Symmetry Medical Inc. | Address: New Bedford Industrial Park, New Bedford, Massachusetts 02745, USA
www.symmetrymedical.com | Phone: +1-(508)-998-4493
Products: Calipers, Flexible Osteotome System, Bone Tamp, Orthopedic Caliper, Reamer (FDA Code: HTO), Screw Removal Systems, ...
Symmetry Medical Inc. manufactures implants, instruments and cases to orthopedic devices. We offer cases and trays that made of metal, plastic or hybrid. We provide forged, cast, machined and finished more...
www.symmetrymedical.com | Phone: +1-(508)-998-4493
Products: Calipers, Flexible Osteotome System, Bone Tamp, Orthopedic Caliper, Reamer (FDA Code: HTO), Screw Removal Systems, ...
Symmetry Medical Inc. manufactures implants, instruments and cases to orthopedic devices. We offer cases and trays that made of metal, plastic or hybrid. We provide forged, cast, machined and finished more...
Hood Laboratories | Address: 575 Washington St., Pembroke, Massachusetts 02359, USA
www.hoodlabs.com | Send Inquiry | Phone: +1-(781)-826-7573, 800-942-5227
FDA Registration: 1220850 Year Established: 1962 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9001:2000, ISO 13485:2003 Certified
Products: Endotracheal Tubes & Accessories, Laryngectomy Tubes, Apnea Therapy Equipment, Bronchial Tube with/without Connector (FDA Code: BTS), Ear Valve, ENT Tracheostomy Tube, Esophageal Prosthesis (FDA Code: ESW), ...
Hood Laboratories offers medical devices for managing specific medical conditions associated with head, neck and chest. We also manufacture laboratory surgical devices. We offer products for use in ot more...
www.hoodlabs.com | Send Inquiry | Phone: +1-(781)-826-7573, 800-942-5227
FDA Registration: 1220850 Year Established: 1962 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9001:2000, ISO 13485:2003 Certified
Products: Endotracheal Tubes & Accessories, Laryngectomy Tubes, Apnea Therapy Equipment, Bronchial Tube with/without Connector (FDA Code: BTS), Ear Valve, ENT Tracheostomy Tube, Esophageal Prosthesis (FDA Code: ESW), ...
Hood Laboratories offers medical devices for managing specific medical conditions associated with head, neck and chest. We also manufacture laboratory surgical devices. We offer products for use in ot more...
Boston Medical Products, Inc. | Address: 117 Flanders Road, Westborough, Massachusetts 01581-1042, USA
www.bosmed.com | Send Inquiry | Phone: +1-(508)-898-9300, 800-433-2674
FDA Registration: 1219795 Year Established: 1980 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Packings, Laryngectomy Tube (FDA Code: KAC), Tracheostomy Tubes, Nasal Splints (FDA Code: EPP), Ear Wick (FDA Code: KCN), Instrument Wipe, ...
Boston Medical Products, Inc. specializes in ENT surgical & respiratory products. We offer otology, rhinology, laryngeal & esophageal, throplasty, pulmonolgy, and Safe-T-Tubes™ airway management more...
www.bosmed.com | Send Inquiry | Phone: +1-(508)-898-9300, 800-433-2674
FDA Registration: 1219795 Year Established: 1980 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Packings, Laryngectomy Tube (FDA Code: KAC), Tracheostomy Tubes, Nasal Splints (FDA Code: EPP), Ear Wick (FDA Code: KCN), Instrument Wipe, ...
Boston Medical Products, Inc. specializes in ENT surgical & respiratory products. We offer otology, rhinology, laryngeal & esophageal, throplasty, pulmonolgy, and Safe-T-Tubes™ airway management more...
Micromedics, Inc. | Address: 1270 Eagan Industrial Rd., St. Paul, Minnesota 55121-1385, USA
www.micromedics.com | Send Inquiry | Phone: +1-(651)-452-1977
FDA Registration: 2183425 Year Established: 1982 Annual Revenues: USD 5-10 Million Employee Count: ~70 Quality: ISO 9001,CE Certified
Products: Arthroscopy Instruments, Ear Implants, Ear Popper, Endoscopes Tray, Ear Speculum (FDA Code: EPY), Applicator, ...
Micromedics, Inc. manufactures, develops, and markets various proprietary medical products. Our product list comprises of implants & instruments for ear, nose & throat (ENT) surgery, products for orga more...
www.micromedics.com | Send Inquiry | Phone: +1-(651)-452-1977
FDA Registration: 2183425 Year Established: 1982 Annual Revenues: USD 5-10 Million Employee Count: ~70 Quality: ISO 9001,CE Certified
Products: Arthroscopy Instruments, Ear Implants, Ear Popper, Endoscopes Tray, Ear Speculum (FDA Code: EPY), Applicator, ...
Micromedics, Inc. manufactures, develops, and markets various proprietary medical products. Our product list comprises of implants & instruments for ear, nose & throat (ENT) surgery, products for orga more...
Premier Products Co. | Address: 1710 Romano Drive, Plymouth Meeting, Pennsylvania 19462, USA
www.premusa.com | Send Inquiry | Phone: +1-(888)-239-6000
FDA Registration: 2521453 Year Established: 1980 Quality: ISO 9001, CE Certified
Products: Curettes, Retractors, Scissors, Electrosurgery, Enzymatic Detergents, Hemostats, ...
Premier Products Co. manufactures & distributes health care products. We are an ISO 9001:2000 and ISO 13485:2003 certified company. The premier evacuator/air filtration system with its distinctly quie more...
www.premusa.com | Send Inquiry | Phone: +1-(888)-239-6000
FDA Registration: 2521453 Year Established: 1980 Quality: ISO 9001, CE Certified
Products: Curettes, Retractors, Scissors, Electrosurgery, Enzymatic Detergents, Hemostats, ...
Premier Products Co. manufactures & distributes health care products. We are an ISO 9001:2000 and ISO 13485:2003 certified company. The premier evacuator/air filtration system with its distinctly quie more...
Gyrus ENT | Address: 2925 Appling Rd, Bartlett, Tennessee 38133, USA
www.retroxhearing.com | Phone: +1-(800)-2623540
FDA Registration: 1037007
Products: Video Otoscopes, Digital Hearing Aids, Surgical Cochlear Implant (FDA Code: MCM), BTE Hearing Aids, Canal Hearing Aids, Industrial, & Specialty Cases, ...
Gyrus ENT deals with otology, sinus and rhinology fields. We offer otology implants, microsurgical instruments, powered dissectors and biomaterials for sinus surgery. Our retrox, a hearing system is d more...
www.retroxhearing.com | Phone: +1-(800)-2623540
FDA Registration: 1037007
Products: Video Otoscopes, Digital Hearing Aids, Surgical Cochlear Implant (FDA Code: MCM), BTE Hearing Aids, Canal Hearing Aids, Industrial, & Specialty Cases, ...
Gyrus ENT deals with otology, sinus and rhinology fields. We offer otology implants, microsurgical instruments, powered dissectors and biomaterials for sinus surgery. Our retrox, a hearing system is d more...
Instrumed, Inc. | Address: 19495 144th Ave NE #B-210, Woodinville, Washington 98072, USA
www.instrumedinc.com | Send Inquiry | Phone: +1-(425)-486 4340
FDA Registration: 1811755
Products: Tourniquets, Tourniquet System, Tourniquet with Pump, Single Channel Tourniquet, Limb Protection Sleeve, Sterile Extension Tubing, ...
Instrumed, Inc. develops and markets medical devices used during orthopedic surgery of the arms & legs. We manufacture orthopedic surgical equipment, urological stents, urological surgical catheters, more...
www.instrumedinc.com | Send Inquiry | Phone: +1-(425)-486 4340
FDA Registration: 1811755
Products: Tourniquets, Tourniquet System, Tourniquet with Pump, Single Channel Tourniquet, Limb Protection Sleeve, Sterile Extension Tubing, ...
Instrumed, Inc. develops and markets medical devices used during orthopedic surgery of the arms & legs. We manufacture orthopedic surgical equipment, urological stents, urological surgical catheters, more...
Living-Forever Co., Ltd. | Address: 9f.-1, No.32, Alley 15, Lane 136, Kangle St., Neihu District, Taipei City 114, Taiwan 
www.living-forever.com | Phone: +886-(2)-26348894
Quality: ISO 13485 Certified
Products: Massagers, Blood Pressure Monitors, Hearing Aids, Non-Invasive Blood-Pressure Measurement System (FDA Code: DXN), Hip Pedometer, Talking Pedometer with FM Radio, ...
Living-Forever Co., Ltd. manufactures and exports a variety of medical devices, and healthcare products such as blood pressure monitors, step counters, slim exercisers and ventral massagers. Our blood more...
www.living-forever.com | Phone: +886-(2)-26348894
Quality: ISO 13485 Certified
Products: Massagers, Blood Pressure Monitors, Hearing Aids, Non-Invasive Blood-Pressure Measurement System (FDA Code: DXN), Hip Pedometer, Talking Pedometer with FM Radio, ...
Living-Forever Co., Ltd. manufactures and exports a variety of medical devices, and healthcare products such as blood pressure monitors, step counters, slim exercisers and ventral massagers. Our blood more...
Combined Instruments (Pvt.), Ltd. | Address: 13-A Model Town, Ugoki, Sailkot, Pakistan
Phone: +92-(432)-510243
Products: Adenoid Punches (FDA Code: KBS), Adult Tongue Depressor (FDA Code: FMA), Adjustable Frequency Tuning Fork, A.V.Fistula Needle Set, A.V. Fistula Needle, Acoustical Fetal Holograph (FDA Code: HHX), ...
Combined Instruments (Pvt.), Ltd. is a manufacturer and exporter of general surgery instruments. Our products include cotton applicators, scalpel blades, depth gauge, ear speculum holders, biopsy & su more...
Phone: +92-(432)-510243
Products: Adenoid Punches (FDA Code: KBS), Adult Tongue Depressor (FDA Code: FMA), Adjustable Frequency Tuning Fork, A.V.Fistula Needle Set, A.V. Fistula Needle, Acoustical Fetal Holograph (FDA Code: HHX), ...
Combined Instruments (Pvt.), Ltd. is a manufacturer and exporter of general surgery instruments. Our products include cotton applicators, scalpel blades, depth gauge, ear speculum holders, biopsy & su more...
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FDA Code / Regulation: KAM / 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.
