Surgical Retractor Suppliers
Limit companies to: Worldwide USA
Glorious Mercantile Corp. (Pvt) Ltd. | Address: 15 - A, Small Industrial Estate, Sialkot, Punjab, Pakistan
www.glorious-group.com | Send Inquiry | Phone: +92-(52)-3256017, 3255528
FDA Registration: 8040263 Quality: ISO 9001:2000 and ISO 13485:2003 Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Surgical Retractor Systems (FDA Code: GAD), Scalpel Handle (FDA Code: GDZ), Uterine Sounds (FDA Code: HHM), Tracheal Dilators (FDA Code: KCG), ...
Glorious Mercantile Corp. (Pvt) Ltd. is a manufacturer and exporter of surgical, dental, veterinary, laboratory and all related beauty health care instruments to doctors, hospitals & health service ag more...
www.glorious-group.com | Send Inquiry | Phone: +92-(52)-3256017, 3255528
FDA Registration: 8040263 Quality: ISO 9001:2000 and ISO 13485:2003 Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Surgical Retractor Systems (FDA Code: GAD), Scalpel Handle (FDA Code: GDZ), Uterine Sounds (FDA Code: HHM), Tracheal Dilators (FDA Code: KCG), ...
Glorious Mercantile Corp. (Pvt) Ltd. is a manufacturer and exporter of surgical, dental, veterinary, laboratory and all related beauty health care instruments to doctors, hospitals & health service ag more...
Mount Blonck Trading. | Address: 1233/6 Cantt., Sialkot, Punjab 51310, Pakistan
www.mountblonck.com | Send Inquiry | Phone: +92-(52)-4273830
FDA Registration: 3002675176 Year Established: 1996 Quality: ISO 9001,ISO: 13485, CE Certified
Products: Probes (FDA Code: HXB), Surgical Retractor Systems (FDA Code: GAD), Ring Cutters (FDA Code: FNS), Tracheal Dilators (FDA Code: KCG), Laser Power Probe, Laparoscopic Probes, ...
Mount Blonck Trading Co. manufactures and exports surgical instruments, dental instruments, veterinary instruments, & scissors. We specialize in the manufacturing of scissors. Our product list compris more...
www.mountblonck.com | Send Inquiry | Phone: +92-(52)-4273830
FDA Registration: 3002675176 Year Established: 1996 Quality: ISO 9001,ISO: 13485, CE Certified
Products: Probes (FDA Code: HXB), Surgical Retractor Systems (FDA Code: GAD), Ring Cutters (FDA Code: FNS), Tracheal Dilators (FDA Code: KCG), Laser Power Probe, Laparoscopic Probes, ...
Mount Blonck Trading Co. manufactures and exports surgical instruments, dental instruments, veterinary instruments, & scissors. We specialize in the manufacturing of scissors. Our product list compris more...
M & M Dental Corp. | Address: Jinnah Street, Mujahid Pura, Sialkot, Punjab, Pakistan
Phone: +92-(703)-5410196
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Retractor Systems (FDA Code: GAD), Scalpel Handle (FDA Code: GDZ), Uterine Sounds (FDA Code: HHM), ...
M & M Dental Corp. specializes in the production of bone clamp, circumcision clamp, ring, disposable surgical instruments, ear cannula and crimp pliers. We provide ear curette, ENT elevator, ENT troca more...
Phone: +92-(703)-5410196
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Retractor Systems (FDA Code: GAD), Scalpel Handle (FDA Code: GDZ), Uterine Sounds (FDA Code: HHM), ...
M & M Dental Corp. specializes in the production of bone clamp, circumcision clamp, ring, disposable surgical instruments, ear cannula and crimp pliers. We provide ear curette, ENT elevator, ENT troca more...
Falcon Surgical Co (Pvt) Ltd. | Address: Wazirabad Rd., P.O. Box 134, Near Village Golophala Ugoki, Sialkot, Punjab, Pakistan
www.falcondental.com.pk | Send Inquiry | Phone: +92-(52)-3510072
Quality: ISO9001:2000,CE Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), ...
Falcon Surgical Co (Pvt) Ltd. is engaged in the production of dental single use instruments, surgical, body care, veterinary, microscopy, scissors and orthognathic instruments. We provide surgical pro more...
www.falcondental.com.pk | Send Inquiry | Phone: +92-(52)-3510072
Quality: ISO9001:2000,CE Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), ...
Falcon Surgical Co (Pvt) Ltd. is engaged in the production of dental single use instruments, surgical, body care, veterinary, microscopy, scissors and orthognathic instruments. We provide surgical pro more...
Surgimax Instruments | Address: P. O. Box # 822, Surgimax Instruments, Defence Road, Sialkot, Punjab 51310, Pakistan
www.surgimax.com.pk | Send Inquiry | Phone: +92-(52)-3560155
Products: Forceps (FDA Code: HTD), Bone Rongeurs, General Surgical Instruments, Bone Curettes, Instruments surgical, Surgical Scissors, ...
Surgimax Instruments manufactures & distributes medical goods including surgical instruments, dental instruments, and scissors. Our surgical instruments comprise of diagnostic & anesthesia instruments more...
www.surgimax.com.pk | Send Inquiry | Phone: +92-(52)-3560155
Products: Forceps (FDA Code: HTD), Bone Rongeurs, General Surgical Instruments, Bone Curettes, Instruments surgical, Surgical Scissors, ...
Surgimax Instruments manufactures & distributes medical goods including surgical instruments, dental instruments, and scissors. Our surgical instruments comprise of diagnostic & anesthesia instruments more...
Sitec (Pvt.) Ltd. | Address: Barlass Street, Kashmir Road, Sialkot, Punjab 51310, Pakistan
Phone: +92-(52)-6938190
FDA Registration: 3007773213
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Retractor Systems (FDA Code: GAD), Scalpel Handle (FDA Code: GDZ), Rib Rongeurs (FDA Code: HTX), Soft Ear Speculum (FDA Code: EPY), ...
Sitec (Pvt.) Ltd. provides bone skids, ear speculums, forceps, gastroenterologic needle holders, general & plastic surgery forceps and general & plastic surgery surgical elevators. We offer general su more...
Phone: +92-(52)-6938190
FDA Registration: 3007773213
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Retractor Systems (FDA Code: GAD), Scalpel Handle (FDA Code: GDZ), Rib Rongeurs (FDA Code: HTX), Soft Ear Speculum (FDA Code: EPY), ...
Sitec (Pvt.) Ltd. provides bone skids, ear speculums, forceps, gastroenterologic needle holders, general & plastic surgery forceps and general & plastic surgery surgical elevators. We offer general su more...
Eltek Instruments (Pvt.) Ltd. | Address: 10 Km Wazirabad Road, Raipur Sialkot, Sialkot, Punjab 51310, Pakistan
Phone: +92-(52)-351-0690
FDA Registration: 3006487092
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Retractor Systems (FDA Code: GAD), Scalpel Handle (FDA Code: GDZ), Rib Rongeurs (FDA Code: HTX), General use Surgical Curettes (FDA Code: FZS), ...
Eltek Instruments (Pvt.) Ltd. deals with surgical instruments such as bone skids, ear speculums, forceps, general & plastic surgery surgical hooks, surgical curettes, surgical pliers and surgical spon more...
Phone: +92-(52)-351-0690
FDA Registration: 3006487092
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Retractor Systems (FDA Code: GAD), Scalpel Handle (FDA Code: GDZ), Rib Rongeurs (FDA Code: HTX), General use Surgical Curettes (FDA Code: FZS), ...
Eltek Instruments (Pvt.) Ltd. deals with surgical instruments such as bone skids, ear speculums, forceps, general & plastic surgery surgical hooks, surgical curettes, surgical pliers and surgical spon more...
Landen Tools Inc. | Address: Khan Street Amanat Pura, Jammu Road, Sialkot, Punjab 51310, Pakistan
www.landentools.com | Send Inquiry | Phone: +92-(52)-4581319
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Gastroenterologic Needle Holder (FDA Code: FHQ), Lacrimal Probes (FDA Code: HNL), Tongue Depressors (FDA Code: FMA), Surgical Retractor Systems (FDA Code: GAD), ...
Landen Tools Inc. specializes in producing custom medical and beauty tools. Our medical products include anesthesia instruments, diagnostic instruments, forceps and general instruments. We offer medic more...
www.landentools.com | Send Inquiry | Phone: +92-(52)-4581319
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Gastroenterologic Needle Holder (FDA Code: FHQ), Lacrimal Probes (FDA Code: HNL), Tongue Depressors (FDA Code: FMA), Surgical Retractor Systems (FDA Code: GAD), ...
Landen Tools Inc. specializes in producing custom medical and beauty tools. Our medical products include anesthesia instruments, diagnostic instruments, forceps and general instruments. We offer medic more...
Technimen Agha (pvt) Ltd | Address: Tecnimen Agha (pvt) Ltd, Kashmir Road, Sialkot, Punjab 51310, Pakistan
www.technimen.com | Send Inquiry | Phone: +92-(52)-4263834
FDA Registration: 3007057998
Products: Gynecology Instruments, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Retractors, Scissors, Sutures, ...
Technimen Agha (pvt) Ltd focuses on surgical instruments. Our surgical products include scalpel handles, scissors, artery forceps, retractors, probes, applicators, spatulas, suture, bone surgery produ more...
www.technimen.com | Send Inquiry | Phone: +92-(52)-4263834
FDA Registration: 3007057998
Products: Gynecology Instruments, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Retractors, Scissors, Sutures, ...
Technimen Agha (pvt) Ltd focuses on surgical instruments. Our surgical products include scalpel handles, scissors, artery forceps, retractors, probes, applicators, spatulas, suture, bone surgery produ more...
Kelsar, S.A. | Address: Blvd. Insurgentes, Libriamento a La, La Mesa 37, Tijuana 22450, Mexico
Phone: +52-(0)-89-41-86
FDA Registration: 9610849
Products: Urethral Catheters (FDA Code: GBM), Urinary Leg Bags, Pediatric Urethral Catheters, Volumetric Infusion Pumps, Urine Collection Leg Bags (FDA Code: FAQ), Non-Absorbable Sutures (FDA Code: GAO), ...
Kelsar, S.A. specializes in offering catheter bags, intraventricular probes and oxygen & bag feeder. Our Argyle DeLee suction catheter with mucous trap is intended to aspirate liquids or semisolids fr more...
Phone: +52-(0)-89-41-86
FDA Registration: 9610849
Products: Urethral Catheters (FDA Code: GBM), Urinary Leg Bags, Pediatric Urethral Catheters, Volumetric Infusion Pumps, Urine Collection Leg Bags (FDA Code: FAQ), Non-Absorbable Sutures (FDA Code: GAO), ...
Kelsar, S.A. specializes in offering catheter bags, intraventricular probes and oxygen & bag feeder. Our Argyle DeLee suction catheter with mucous trap is intended to aspirate liquids or semisolids fr more...
Goval Internacional S.A. De C.V. | Address: Washington 3000 Pte., Col. Deportivo Obispado, Monterrey, MX-NLE 64040, Mexico
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Surgical Retractor Systems (FDA Code: GAD), Lacrimal Dilator (FDA Code: HNW), ...
Goval Internacional S.A. De C.V. is a provider of surgical and diagnostic equipments. more...
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Surgical Retractor Systems (FDA Code: GAD), Lacrimal Dilator (FDA Code: HNW), ...
Goval Internacional S.A. De C.V. is a provider of surgical and diagnostic equipments. more...
U&i Corp. | Address: 529-1 Yonghyun-Dong, Euijungbu, Kyunggi-Do 480-050, Korea, Republic Of 
Phone: +82-(31)-852 0102
FDA Registration: 9617297
Products: Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Drill Bit (FDA Code: HTW), ...
U&i Corp. deals with benders, bending/contouring instruments, bone rasps, bone taps, compression instruments and depth gauges. We also offer socket pusher, spinal interlaminal fixation, spinal interve more...
Phone: +82-(31)-852 0102
FDA Registration: 9617297
Products: Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Drill Bit (FDA Code: HTW), ...
U&i Corp. deals with benders, bending/contouring instruments, bone rasps, bone taps, compression instruments and depth gauges. We also offer socket pusher, spinal interlaminal fixation, spinal interve more...
Jeil Medical Corporation | Address: No. 702, Kolon Science Valley 2nd, 822, Guro-Dong, Guro-Gu, Seoul-City, Korea, Republic Of
www.jeilmed.co.kr | Send Inquiry | Phone: +82-(2)-850-3500
FDA Registration: 3004049923
Products: Forceps (FDA Code: HTD), Surgical Retractor Systems (FDA Code: GAD), Drill Bit (FDA Code: HTW), Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Wire Cutters (FDA Code: HXZ), ...
Jeil Medical Corporation is a manufacturer of orthodontic screw and oral maxilla facial fixation system. We also distribute dental implant system and instrument. Our Orthonia motor torque driver is a more...
www.jeilmed.co.kr | Send Inquiry | Phone: +82-(2)-850-3500
FDA Registration: 3004049923
Products: Forceps (FDA Code: HTD), Surgical Retractor Systems (FDA Code: GAD), Drill Bit (FDA Code: HTW), Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Wire Cutters (FDA Code: HXZ), ...
Jeil Medical Corporation is a manufacturer of orthodontic screw and oral maxilla facial fixation system. We also distribute dental implant system and instrument. Our Orthonia motor torque driver is a more...
Zerone | Address: 124-3 Ojeon-Dong, Uiwang-Si, KR-41 421170, Korea, Republic Of
Products: Common Surgical Instrument, Surgical Retractor Systems (FDA Code: GAD), Surgical Retractor (FDA Code: GAD), Disposable Surgical Instrument (FDA Code: KDC), ...
Zerone specializes in offering surgical instruments. more...
Products: Common Surgical Instrument, Surgical Retractor Systems (FDA Code: GAD), Surgical Retractor (FDA Code: GAD), Disposable Surgical Instrument (FDA Code: KDC), ...
Zerone specializes in offering surgical instruments. more...
Olympus Imaging Corporation | Address: 3-1 Nishi-Shinjuku 2-chome, Shinjuku-ku, Tokyo 163-0914, Japan
www.olympus.co.jp | Phone: +81-(3)-3340-2111
FDA Registration: 8010047
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Lacrimal Probes (FDA Code: HNL), Arthroscopes (FDA Code: HRX), Powered Surgical Laser Instrument (FDA Code: GEX), Resectoscopes (FDA Code: FJL), Surgical Drapes & Packs (FDA Code: KKX), ...
Olympus Imaging Corporation specializes in medical endoscopes and surgical products,artificial bone replacement material and dental products. We also deal with microscopes and the medical information more...
www.olympus.co.jp | Phone: +81-(3)-3340-2111
FDA Registration: 8010047
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Lacrimal Probes (FDA Code: HNL), Arthroscopes (FDA Code: HRX), Powered Surgical Laser Instrument (FDA Code: GEX), Resectoscopes (FDA Code: FJL), Surgical Drapes & Packs (FDA Code: KKX), ...
Olympus Imaging Corporation specializes in medical endoscopes and surgical products,artificial bone replacement material and dental products. We also deal with microscopes and the medical information more...
Endogun Medical Systems | Address: Kibbutz Haogen, Kibbutz Haogen 42880, Israel
www.endogun.com | Send Inquiry | Phone: +972-(9)-8987033
Products: Pelvic External Fixators, Anastomosis Clamps, Surgical Retractor Systems (FDA Code: GAD), Urinary Incontinence Cuffs, Anterior Cervical Fusion Longitudinal Retractor, Instruments for Minimally Invasive Surgery, ...
Endogun Medical Systems Ltd. provides soft tissue attachment products for minimally invasive surgery. Our products include Endogun's EndoFast Reliant™ system and VT guide. Our Endogun's EndoFast more...
www.endogun.com | Send Inquiry | Phone: +972-(9)-8987033
Products: Pelvic External Fixators, Anastomosis Clamps, Surgical Retractor Systems (FDA Code: GAD), Urinary Incontinence Cuffs, Anterior Cervical Fusion Longitudinal Retractor, Instruments for Minimally Invasive Surgery, ...
Endogun Medical Systems Ltd. provides soft tissue attachment products for minimally invasive surgery. Our products include Endogun's EndoFast Reliant™ system and VT guide. Our Endogun's EndoFast more...
Virtual Ports Ltd | Address: 6 Kahol Street,, Teradion Industrial Park, Misgav 20179, Israel
https://virtual-ports.com | Send Inquiry | Phone: +972-(4)-999-0189
FDA Registration: 3006169466
Products: Surgical Retractor Systems (FDA Code: GAD), Surgical Retractor (FDA Code: GAD), General & Plastic Surgery Laparoscope (FDA Code: GCJ), ...
Virtual Ports Ltd specializes in developing and marketing instruments to improve minimally invasive laparoscopic procedures. We provide EndoClear™. It is a device which is anchored within the ca more...
https://virtual-ports.com | Send Inquiry | Phone: +972-(4)-999-0189
FDA Registration: 3006169466
Products: Surgical Retractor Systems (FDA Code: GAD), Surgical Retractor (FDA Code: GAD), General & Plastic Surgery Laparoscope (FDA Code: GCJ), ...
Virtual Ports Ltd specializes in developing and marketing instruments to improve minimally invasive laparoscopic procedures. We provide EndoClear™. It is a device which is anchored within the ca more...
Kaushik Orthopaedic Corp., New Delhi | Address: 23/4, Chaddha Bhawan, Shakti Nagar, Behind Parmarth Mission Hospital, New Delhi, Delhi 110 007, India 
www.orthopaedic-implants-india.com | Send Inquiry | Phone: +91-(11)-23840700/2384607
Products: Surgical Retractor Systems (FDA Code: GAD), Hip Prosthesis, Surgical Clamps, Electric Plaster Saws, Bipolar Hip Prosthesis, Hip Products, ...
Kaushik Orthopaedic Corp., New Delhi is a manufacturer and exporter of orthopedic implants & orthopedic instruments. We offer Hip Prosthesis, bone cutters, surgical chisels, surgical implants, surgica more...
www.orthopaedic-implants-india.com | Send Inquiry | Phone: +91-(11)-23840700/2384607
Products: Surgical Retractor Systems (FDA Code: GAD), Hip Prosthesis, Surgical Clamps, Electric Plaster Saws, Bipolar Hip Prosthesis, Hip Products, ...
Kaushik Orthopaedic Corp., New Delhi is a manufacturer and exporter of orthopedic implants & orthopedic instruments. We offer Hip Prosthesis, bone cutters, surgical chisels, surgical implants, surgica more...
General Surgical Co., (india) Pvt. Ltd. | Address: G-6 Gee Cee Crescent, 114, Ponamallee High Road, Chennai, Tamil Nadu 60084, India
www.gescoindia.com | Send Inquiry | Phone: +91-(44)-2825 96 02
FDA Registration: 9613926 Quality: ISO 9001:2000 Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Surgical Marking Pens (FDA Code: HRP), Gastroenterologic Needle Holder (FDA Code: FHQ), ...
General Surgical Co., (india) Pvt. Ltd. is a manufacturer of surgical instruments. We produce medical & surgical disposables, general, ENT, neuro & spinal, orthopedic, gynecology & obstetrics, plastic more...
www.gescoindia.com | Send Inquiry | Phone: +91-(44)-2825 96 02
FDA Registration: 9613926 Quality: ISO 9001:2000 Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Surgical Marking Pens (FDA Code: HRP), Gastroenterologic Needle Holder (FDA Code: FHQ), ...
General Surgical Co., (india) Pvt. Ltd. is a manufacturer of surgical instruments. We produce medical & surgical disposables, general, ENT, neuro & spinal, orthopedic, gynecology & obstetrics, plastic more...
Medicor Hand Instrument Co. | Address: Furedi Ut 98, Debrecen, Hungary
Phone: +36-(52)-310696
FDA Registration: 9680519
Products: Forceps (FDA Code: HTD), Uterine Sound Instruments, Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Vascular Clamps (FDA Code: DXC), Uterine Sound Devices, ...
Medicor Hand Instrument Co. is a manufacturer and seller of medical hand instruments. We are an ISO 9002 certified company. Our product line includes knives, scalpels, scissors, forceps, needle holder more...
Phone: +36-(52)-310696
FDA Registration: 9680519
Products: Forceps (FDA Code: HTD), Uterine Sound Instruments, Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Vascular Clamps (FDA Code: DXC), Uterine Sound Devices, ...
Medicor Hand Instrument Co. is a manufacturer and seller of medical hand instruments. We are an ISO 9002 certified company. Our product line includes knives, scalpels, scissors, forceps, needle holder more...
Sponsored Links
FDA Code / Regulation: GAD / 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.
