Automatic Surgical Stapler Suppliers
Limit companies to: Worldwide USA
Lyons Tool and Die Company | Address: 185 Research Parkway, Meriden, Connecticut 06450, USA 
www.lyonstool.com | Send Inquiry | Phone: +1-(203)-238-2689, (800)-422-9363
Year Established: 1951 Annual Revenues: USD 10-25 Million Employee Count: ~40 Quality: ISO 9001, ISO 9002, CE Certified
Products: Consulting Services, Contract Manufacturers, Surgical Blades, Surgical Staplers, Circular Staplers, Surgical Staplers, Titanium Staples, Surgical Staplers, Stainless Steel Staples, ...
Lyons Tool and Die Company specializes in precision metal stamping manufacturing. We are an ISO 9001:2000 certified company. We are a full service supplier of medical devices and components. We provid more...
www.lyonstool.com | Send Inquiry | Phone: +1-(203)-238-2689, (800)-422-9363
Year Established: 1951 Annual Revenues: USD 10-25 Million Employee Count: ~40 Quality: ISO 9001, ISO 9002, CE Certified
Products: Consulting Services, Contract Manufacturers, Surgical Blades, Surgical Staplers, Circular Staplers, Surgical Staplers, Titanium Staples, Surgical Staplers, Stainless Steel Staples, ...
Lyons Tool and Die Company specializes in precision metal stamping manufacturing. We are an ISO 9001:2000 certified company. We are a full service supplier of medical devices and components. We provid more...
Autosuture | Address: 150 Glover Avenue, Norwalk, Connecticut 06856, USA
www.autosuture.com | Send Inquiry | Phone: +1-(800)-722-8772
Annual Revenues: > USD 1 Billion Employee Count: ~5780 Quality: ISO 9001, ISO 9002, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Retractors, Scissors, Sutures, Needles, ...
Autosuture offers a complete line of surgical products and instrumentation that surgeons utilize for laparoscopic, endoscopic & traditional open surgical procedures & lymphatic mapping. We are an ISO more...
www.autosuture.com | Send Inquiry | Phone: +1-(800)-722-8772
Annual Revenues: > USD 1 Billion Employee Count: ~5780 Quality: ISO 9001, ISO 9002, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Retractors, Scissors, Sutures, Needles, ...
Autosuture offers a complete line of surgical products and instrumentation that surgeons utilize for laparoscopic, endoscopic & traditional open surgical procedures & lymphatic mapping. We are an ISO more...
Theragenics Corporation | Address: 5203 Bristol Industrial Way, Buford, Georgia 30518, USA
www.theragenics.com | Phone: +1-(770)-271-0233
FDA Registration: 3013378804 Year Established: 1981 Annual Revenues: USD 25-50 Million Employee Count: ~160 Quality: CE Certified
Products: Needles, Radiation Plaques, Catheter Introducers (FDA Code: DYB), Wound Closures, Vitreoretinal Surgery, Radiation Plaques, Bone Wax (FDA Code: MTJ), ...
Theragenics Corporation is a medical device company serving the cancer treatment and surgical markets. We offer specialty needles, RF Devices, implanter and introducer products, surgery, vascular, onc more...
www.theragenics.com | Phone: +1-(770)-271-0233
FDA Registration: 3013378804 Year Established: 1981 Annual Revenues: USD 25-50 Million Employee Count: ~160 Quality: CE Certified
Products: Needles, Radiation Plaques, Catheter Introducers (FDA Code: DYB), Wound Closures, Vitreoretinal Surgery, Radiation Plaques, Bone Wax (FDA Code: MTJ), ...
Theragenics Corporation is a medical device company serving the cancer treatment and surgical markets. We offer specialty needles, RF Devices, implanter and introducer products, surgery, vascular, onc more...
Ethicon, Inc. | Address: P.O. Box 151,Route 22 West, Somerville, New Jersey 08876, USA
www.ethicon.com | Send Inquiry | Phone: +1-(800)-888-9234
FDA Registration: 3003702646 Employee Count: ~9000
Products: Umbilical Tapes, Forceps (FDA Code: HTD), Scissors, Sutures, Surgicel, Dissectors, ...
Ethicon, Inc. is a global medical device company, which specializes in surgical sutures. Our product portfolio comprises of aesthetic medicine, biosurgicals, hernia solutions, infection control, pelvi more...
www.ethicon.com | Send Inquiry | Phone: +1-(800)-888-9234
FDA Registration: 3003702646 Employee Count: ~9000
Products: Umbilical Tapes, Forceps (FDA Code: HTD), Scissors, Sutures, Surgicel, Dissectors, ...
Ethicon, Inc. is a global medical device company, which specializes in surgical sutures. Our product portfolio comprises of aesthetic medicine, biosurgicals, hernia solutions, infection control, pelvi more...
Conmed Corporation | Address: 525 French Road, Utica, New York 13502, USA
www.conmed.com | Send Inquiry | Phone: +1-(315)-797-8375
FDA Registration: 1223925 Year Established: 1970 Employee Count: ~2300
Products: Audiometers & Tympanometers, Otoscopes, Forceps (FDA Code: HTD), Scissors, Bipolar Cautery Systems, Monopolar Cautery Systems, ...
Conmed Corporation specializes in the fields of gastroenterology & pulmonology. Our bite block's patented integral tongue depressor offers easier esophageal intubation with direct visualization & decr more...
www.conmed.com | Send Inquiry | Phone: +1-(315)-797-8375
FDA Registration: 1223925 Year Established: 1970 Employee Count: ~2300
Products: Audiometers & Tympanometers, Otoscopes, Forceps (FDA Code: HTD), Scissors, Bipolar Cautery Systems, Monopolar Cautery Systems, ...
Conmed Corporation specializes in the fields of gastroenterology & pulmonology. Our bite block's patented integral tongue depressor offers easier esophageal intubation with direct visualization & decr 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: Medical Humidifiers, Oxygen Masks (FDA Code: BYG), Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), ...
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: Medical Humidifiers, Oxygen Masks (FDA Code: BYG), Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), ...
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, Tissue Forceps, ...
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, Tissue Forceps, ...
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...
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: Vaginal Retractors (FDA Code: HDL), Curettes, Drills, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Uterine Sound Instruments, ...
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: Vaginal Retractors (FDA Code: HDL), Curettes, Drills, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Uterine Sound Instruments, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou 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, Forceps (FDA Code: HTD), Procedure Trays, Retractors, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
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, Forceps (FDA Code: HTD), Procedure Trays, Retractors, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
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...
Zimmer Dental, Inc. | Address: 1900 Aston Ave., Carlsbad, California 92008, USA
www.zimmerdental.com | Phone: +1-(760)-929-4300, 800-854-7019
FDA Registration: 2023141 Year Established: 1927 Annual Revenues: USD 100-500 Million Employee Count: ~410 Quality: ISO 13485, CE Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Arthroscopes (FDA Code: HRX), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), ...
Zimmer Dental, Inc. specializes in dental implant products. Our product portfolio comprises of root-form endosseous dental implants, prosthetic attachments for restoration, surgical instrumentation, c more...
www.zimmerdental.com | Phone: +1-(760)-929-4300, 800-854-7019
FDA Registration: 2023141 Year Established: 1927 Annual Revenues: USD 100-500 Million Employee Count: ~410 Quality: ISO 13485, CE Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Arthroscopes (FDA Code: HRX), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), ...
Zimmer Dental, Inc. specializes in dental implant products. Our product portfolio comprises of root-form endosseous dental implants, prosthetic attachments for restoration, surgical instrumentation, c more...
Sartorius Stedim SUS Inc. | Address: 1910 Mark Ct., Concord, California 94520, USA
www.sartorius-stedim.com | Send Inquiry | Phone: +1-(925)-689-6650, 800-914-6644
Year Established: 1978 Annual Revenues: USD 25-50 Million Employee Count: ~60 Quality: ISO 9001, ISO 9002 Certified
Products: Incubators, Microcentrifuges, Centrifuges, Containers, Compact High Speed Refrigerated Floor-Standing Centrifuge, Cell Culture Systems, ...
Sartorius Stedim SUS Inc. is a provider of equipments & services for the development, quality assurance and production processes of the biopharmaceutical industry. Our integrated solutions covers ferm more...
www.sartorius-stedim.com | Send Inquiry | Phone: +1-(925)-689-6650, 800-914-6644
Year Established: 1978 Annual Revenues: USD 25-50 Million Employee Count: ~60 Quality: ISO 9001, ISO 9002 Certified
Products: Incubators, Microcentrifuges, Centrifuges, Containers, Compact High Speed Refrigerated Floor-Standing Centrifuge, Cell Culture Systems, ...
Sartorius Stedim SUS Inc. is a provider of equipments & services for the development, quality assurance and production processes of the biopharmaceutical industry. Our integrated solutions covers ferm more...
Tiger Medical Products (us), Inc. | Address: 17328, Ventura Blvd., No. 245, Encino, California 91316, USA
Phone: +1-(310)-614-1997
Products: Tongue Depressors (FDA Code: FMA), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), Patient Examination Gowns and Capes (FDA Code: FME), Automated Urinalysis System (FDA Code: KQO), Urinals (FDA Code: FNP), ...
Tiger Medical Products (us), Inc. provides tongue depressors, adhesive bandages, medical absorbent fibers, mechanical walkers and manual stethoscopes. more...
Phone: +1-(310)-614-1997
Products: Tongue Depressors (FDA Code: FMA), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), Patient Examination Gowns and Capes (FDA Code: FME), Automated Urinalysis System (FDA Code: KQO), Urinals (FDA Code: FNP), ...
Tiger Medical Products (us), Inc. provides tongue depressors, adhesive bandages, medical absorbent fibers, mechanical walkers and manual stethoscopes. more...
Satiety, Inc. | Address: 2470 Embarcadero Way, Palo Alto, California 94303, USA
www.satietyinc.com | Send Inquiry | Phone: +1-(650)-3202100
Products: Obesity/Slimming Equipment, Medical Devices, Automatic Surgical Stapler (FDA Code: GAG), General & Plastic Surgery Forceps (FDA Code: GEN), Implantable Staple (FDA Code: GDW), ...
Satiety, Inc. develops technologies for less invasive treatment of obesity, including the TOGA® system for transoral gastroplasty. The TOGA system is a set of flexible devices designed to be inser more...
www.satietyinc.com | Send Inquiry | Phone: +1-(650)-3202100
Products: Obesity/Slimming Equipment, Medical Devices, Automatic Surgical Stapler (FDA Code: GAG), General & Plastic Surgery Forceps (FDA Code: GEN), Implantable Staple (FDA Code: GDW), ...
Satiety, Inc. develops technologies for less invasive treatment of obesity, including the TOGA® system for transoral gastroplasty. The TOGA system is a set of flexible devices designed to be inser more...
Safestitch Medical | Address: 4400 Biscayne Blvd, Miami, Florida 33137, USA
www.safestitch.com | Phone: +1-(305)-575-4145
Products: Tubal Ligation Kits, Hernia Aid, Airways & Bite Blocks, Bite Guards and Blocks, Obesity/Slimming Equipment, Endoscopic Accessories, Bite Blocks, Dilators, ...
Safestitch Medical develops a prototype for a plainly invasive obesity procedure to build up numerous devices in the areas of bariatric surgery, reflux interventions, barrett's esophagus, hernia r more...
www.safestitch.com | Phone: +1-(305)-575-4145
Products: Tubal Ligation Kits, Hernia Aid, Airways & Bite Blocks, Bite Guards and Blocks, Obesity/Slimming Equipment, Endoscopic Accessories, Bite Blocks, Dilators, ...
Safestitch Medical develops a prototype for a plainly invasive obesity procedure to build up numerous devices in the areas of bariatric surgery, reflux interventions, barrett's esophagus, hernia r more...
Demetech Corp. | Address: 3530 N.w. 115th Ave., Miami, Florida 33178, USA
Phone: +1-(305)-597-5277
FDA Registration: 1064584
Products: Forceps (FDA Code: HTD), Scissors, Sutures, Gastroenterologic Needle Holder (FDA Code: FHQ), Cohesive Bandages, Blood Pressure Monitors, ...
Demetech Corp. offers medical products and equipment.Our products include disposable surgeon's gloves, cotton applicator, blood pressure monitors/kit, suture, polyglycolic acid, surgical nylon suture, more...
Phone: +1-(305)-597-5277
FDA Registration: 1064584
Products: Forceps (FDA Code: HTD), Scissors, Sutures, Gastroenterologic Needle Holder (FDA Code: FHQ), Cohesive Bandages, Blood Pressure Monitors, ...
Demetech Corp. offers medical products and equipment.Our products include disposable surgeon's gloves, cotton applicator, blood pressure monitors/kit, suture, polyglycolic acid, surgical nylon suture, more...
Bio-Bridge Science, Inc. | Address: 1211 West 22nd St., Suite 615, Oak Brook, Illinois 60523, USA
www.bbsinstruments.com | Send Inquiry | Phone: +1-(630)-9280869
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Bone Hooks (FDA Code: KIK), ...
Bio-Bridge Science, Inc. is a provider of surgical and dental instruments. Our surgical instruments include surgical clamps, forceps, scalpel handles, scissors, tweezers and retractors. Our dental ins more...
www.bbsinstruments.com | Send Inquiry | Phone: +1-(630)-9280869
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Bone Hooks (FDA Code: KIK), ...
Bio-Bridge Science, Inc. is a provider of surgical and dental instruments. Our surgical instruments include surgical clamps, forceps, scalpel handles, scissors, tweezers and retractors. Our dental ins more...
Ironwood Plastics, Inc. | Address: 1235 Wall St., Ironwood, Michigan 49938, USA
www.ironwood.com | Send Inquiry | Phone: +1-(906)-932-5025
Products: Surgical Staplers, Circular Staplers, Surgical Staplers, Open Clip Appliers, Automatic Surgical Stapler (FDA Code: GAG), Moisture Analyzers, Stereoscopic Microscopes, ...
Ironwood Plastics, Inc. offers custom injection molded products. We provide surgical staple remover. Our products include close tolerance molding, insert molding, high temperature materials and laser more...
www.ironwood.com | Send Inquiry | Phone: +1-(906)-932-5025
Products: Surgical Staplers, Circular Staplers, Surgical Staplers, Open Clip Appliers, Automatic Surgical Stapler (FDA Code: GAG), Moisture Analyzers, Stereoscopic Microscopes, ...
Ironwood Plastics, Inc. offers custom injection molded products. We provide surgical staple remover. Our products include close tolerance molding, insert molding, high temperature materials and laser more...
Sterilmed, Inc. | Address: 11400 73rd Ave. North, #100, Maple Grove, Minnesota 55369, USA
www.sterilmed.com | Send Inquiry | Phone: +1-(763)-488-3400, 888-252-1542
FDA Registration: 2134070
Products: Oxygen Masks (FDA Code: BYG), Guidewires, Tunnel Blades, Arthroscopes (FDA Code: HRX), Chisels, Electrode Cables (FDA Code: IKD), ...
Sterilmed, Inc. offers reprocessing, repair, and refurbishment of medical devices, equipment, and instruments. We also specialize in the sale of quality pre-owned surgical video equipment. Our pre-own more...
www.sterilmed.com | Send Inquiry | Phone: +1-(763)-488-3400, 888-252-1542
FDA Registration: 2134070
Products: Oxygen Masks (FDA Code: BYG), Guidewires, Tunnel Blades, Arthroscopes (FDA Code: HRX), Chisels, Electrode Cables (FDA Code: IKD), ...
Sterilmed, Inc. offers reprocessing, repair, and refurbishment of medical devices, equipment, and instruments. We also specialize in the sale of quality pre-owned surgical video equipment. Our pre-own more...
Incisive Surgical, Inc. | Address: 14405 - 21st Avenue North, Suite 130, Plymouth, Minnesota 55447, USA
www.insorb.com | Send Inquiry | Phone: +1-(952)-591-2543, 877-246-7672
FDA Registration: 3004028675 Year Established: 1999 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Skin Staplers, Automatic Surgical Stapler (FDA Code: GAG), General & Plastic Surgery Forceps (FDA Code: GEN), Implantable Staple (FDA Code: GDW), Skin Closure Solutions, ...
Incisive Surgical, Inc. develops mechanical surgical solutions for skin closure. Our product is Insorb®. Our Insorb® is a subcuticular skin stapler that is designed to combine the cosmetic res more...
www.insorb.com | Send Inquiry | Phone: +1-(952)-591-2543, 877-246-7672
FDA Registration: 3004028675 Year Established: 1999 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Skin Staplers, Automatic Surgical Stapler (FDA Code: GAG), General & Plastic Surgery Forceps (FDA Code: GEN), Implantable Staple (FDA Code: GDW), Skin Closure Solutions, ...
Incisive Surgical, Inc. develops mechanical surgical solutions for skin closure. Our product is Insorb®. Our Insorb® is a subcuticular skin stapler that is designed to combine the cosmetic res more...
Guidant Corporation | Address: 4100 Hamline Avenue North, St. Paul, Minnesota 55112-5798, USA
www.guidant.com | Phone: +1-(651)-582-4000
Annual Revenues: USD 50-100 Million Employee Count: ~320 Quality: ISO 9001, CE Certified
Products: Guidewires, Anastomosis Assist Tools, Guide Catheter, LCB-side holes, RCB-Side Holes, Directional Atherectomy, Aortic Stent Systems, ...
Guidant Corporation is involved in the design and development of cardiovascular medical products. We offer products for the treatment of arrhythmias, heart failure, coronary artery and peripheral vasc more...
www.guidant.com | Phone: +1-(651)-582-4000
Annual Revenues: USD 50-100 Million Employee Count: ~320 Quality: ISO 9001, CE Certified
Products: Guidewires, Anastomosis Assist Tools, Guide Catheter, LCB-side holes, RCB-Side Holes, Directional Atherectomy, Aortic Stent Systems, ...
Guidant Corporation is involved in the design and development of cardiovascular medical products. We offer products for the treatment of arrhythmias, heart failure, coronary artery and peripheral vasc more...
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FDA Code / Regulation: GAG / 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.
