Reusable Vein Stripper Suppliers
Limit companies to: Worldwide USA
Rolan Instruments Gmbh | Address: 16 Schlangeneckstrasse, Endingen 79346, Germany 
www.rolan-instruments.de | Send Inquiry | Phone: +49-(0)-764-2920516
Products: Amniotome (FDA Code: HGE), Bone Clamp (FDA Code: HXD), Amputation Knife (FDA Code: GDN), Awl (FDA Code: HWJ), Bending/Contouring Instrument (FDA Code: HXP), Bone Trephine (FDA Code: HWK), ...
Rolan Instruments Gmbh is engaged in the business of selling surgical instruments, retractor systems and container systems. more...
www.rolan-instruments.de | Send Inquiry | Phone: +49-(0)-764-2920516
Products: Amniotome (FDA Code: HGE), Bone Clamp (FDA Code: HXD), Amputation Knife (FDA Code: GDN), Awl (FDA Code: HWJ), Bending/Contouring Instrument (FDA Code: HXP), Bone Trephine (FDA Code: HWK), ...
Rolan Instruments Gmbh is engaged in the business of selling surgical instruments, retractor systems and container systems. more...
Rudolf Medical Gmbh + Co. Kg | Address: No. 1 Zollerstr, Fridingen 78567, Germany
www.rudolf-med.com | Phone: +49-(049)-7463-99560
FDA Registration: 8010298
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Rudolf Medical Gmbh + Co. Kg manufactures medical devices, equipments and instruments for open & minimally invasive surgery. The product lines for minimally invasive surgery instruments, endoscopes an more...
www.rudolf-med.com | Phone: +49-(049)-7463-99560
FDA Registration: 8010298
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Rudolf Medical Gmbh + Co. Kg manufactures medical devices, equipments and instruments for open & minimally invasive surgery. The product lines for minimally invasive surgery instruments, endoscopes an more...
Waldemar Link GmbH & Co. KG | Address: Barkhausenweg 10, Hamburg D-22339, Germany
www.waldemarlink.com | Send Inquiry | Phone: +49-(40)-539950
FDA Registration: 3004371426
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Flexible Depth Gauge (FDA Code: HTJ), Uncemented Metal/Polymer Semi-Constrained Hip Prosthesis (FDA Code: LWJ), Cemented Metal/Polymer Semi-Constrained Hip Prosthesis (FDA Code: JDI), Nose And Throat Ear Bur (FDA Code: EQJ), ...
Waldemar Link GmbH & Co. KG specializes in supplying hospital products. We also manufacture orthopedic implants and surgical instruments. Our implants are manufactured under high-tech conditions. Our more...
www.waldemarlink.com | Send Inquiry | Phone: +49-(40)-539950
FDA Registration: 3004371426
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Flexible Depth Gauge (FDA Code: HTJ), Uncemented Metal/Polymer Semi-Constrained Hip Prosthesis (FDA Code: LWJ), Cemented Metal/Polymer Semi-Constrained Hip Prosthesis (FDA Code: JDI), Nose And Throat Ear Bur (FDA Code: EQJ), ...
Waldemar Link GmbH & Co. KG specializes in supplying hospital products. We also manufacture orthopedic implants and surgical instruments. Our implants are manufactured under high-tech conditions. Our more...
Richard Wolf GmbH | Address: Pforzheimer Str. 32, Knittlingen 75438, Germany
www.richard-wolf.com | Send Inquiry | Phone: +49-(7043)-35-0
FDA Registration: 9611102 Employee Count: ~20
Products: Light Sources, Flexible, Stabilization and Steering, Endoscopic Carpal Tunnel Release Systems, Arthroscopes (FDA Code: HRX), Cameras, ...
Richard Wolf GmbH develops endoscopes and modular system solutions for all medical fields. We are accredited with ISO9001 and ISO 13485 certification. Our nephroscopy is used to removal of kidney ston more...
www.richard-wolf.com | Send Inquiry | Phone: +49-(7043)-35-0
FDA Registration: 9611102 Employee Count: ~20
Products: Light Sources, Flexible, Stabilization and Steering, Endoscopic Carpal Tunnel Release Systems, Arthroscopes (FDA Code: HRX), Cameras, ...
Richard Wolf GmbH develops endoscopes and modular system solutions for all medical fields. We are accredited with ISO9001 and ISO 13485 certification. Our nephroscopy is used to removal of kidney ston more...
Zepf Medical Instruments GmbH | Address: 21 Gunninger St., Seitingen-Oberflacht D-78606, Germany
www.zepf-medical-instruments.de | Send Inquiry | Phone: +49-(7464)-98506-0
FDA Registration: 3003244954
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Laser Power Probe, Laparoscopic Probes, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ...
Zepf Medical Instruments GmbH is a manufacturer of medical instruments and related products. We keep in stock a full range of surgical instruments and related items. more...
www.zepf-medical-instruments.de | Send Inquiry | Phone: +49-(7464)-98506-0
FDA Registration: 3003244954
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Laser Power Probe, Laparoscopic Probes, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ...
Zepf Medical Instruments GmbH is a manufacturer of medical instruments and related products. We keep in stock a full range of surgical instruments and related items. more...
AS Medizintechnik Gmbh | Address: Sattlerstrasse 15, Tuttlingen 78532, Germany
www.as-medizintechnik.de | Send Inquiry | Phone: +49-(7461)-966326
Products: Amniotome (FDA Code: HGE), Adenoid Curettes (FDA Code: KBJ), Adenotomes (FDA Code: KBH), Amputation Knife (FDA Code: GDN), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Antrum Perforator (FDA Code: KAT), ...
AS Medizintechnik Gmbh specializes in the production of surgical instruments and disposal sterile products. Our product line comprises of non-stick bipolar forceps, propylux, detachable laminectomy an more...
www.as-medizintechnik.de | Send Inquiry | Phone: +49-(7461)-966326
Products: Amniotome (FDA Code: HGE), Adenoid Curettes (FDA Code: KBJ), Adenotomes (FDA Code: KBH), Amputation Knife (FDA Code: GDN), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Antrum Perforator (FDA Code: KAT), ...
AS Medizintechnik Gmbh specializes in the production of surgical instruments and disposal sterile products. Our product line comprises of non-stick bipolar forceps, propylux, detachable laminectomy an more...
A.Handte Medizintechnik Gmbh & Co. Kg | Address: Ehrenbergstrasse 39, Tuttlingen D-78532, Germany
Phone: +49-(074)-61-15337
FDA Registration: 8010155
Products: Ear Curette (FDA Code: JYG), Ear Spoon (FDA Code: JZE), ENT Elevator (FDA Code: KAD), Mastoid Chisel (FDA Code: JYD), Mastoid Gauge (FDA Code: JYI), Middle Ear Chisel (FDA Code: JYE), ...
A.Handte Medizintechnik Gmbh & Co. Kg offers cardio vascular instruments. more...
Phone: +49-(074)-61-15337
FDA Registration: 8010155
Products: Ear Curette (FDA Code: JYG), Ear Spoon (FDA Code: JZE), ENT Elevator (FDA Code: KAD), Mastoid Chisel (FDA Code: JYD), Mastoid Gauge (FDA Code: JYI), Middle Ear Chisel (FDA Code: JYE), ...
A.Handte Medizintechnik Gmbh & Co. Kg offers cardio vascular instruments. more...
A. Henniss Medizintechnik | Address: Mohlstrasse 65, Postfach 4332, Tuttlingen D-78532, Germany
www.henniss-med.com | Send Inquiry | Phone: +49-(7461)-3452
Products: Wire Twisters (FDA Code: HXS), Ophthalmic Suture Scissors (FDA Code: HNF), General & Plastic Surgery Forceps (FDA Code: GEN), Surgical Punch (FDA Code: LRY), Disposable Medical Scissors (FDA Code: JOK), Surgical Knife (FDA Code: EMF), ...
A. Henniss Medizintechnik specializes in offering surgical instrument markers. We mainly manufacture products for orthopedics. We offer products for general surgery, ENT, thoracic & vascular, obstetri more...
www.henniss-med.com | Send Inquiry | Phone: +49-(7461)-3452
Products: Wire Twisters (FDA Code: HXS), Ophthalmic Suture Scissors (FDA Code: HNF), General & Plastic Surgery Forceps (FDA Code: GEN), Surgical Punch (FDA Code: LRY), Disposable Medical Scissors (FDA Code: JOK), Surgical Knife (FDA Code: EMF), ...
A. Henniss Medizintechnik specializes in offering surgical instrument markers. We mainly manufacture products for orthopedics. We offer products for general surgery, ENT, thoracic & vascular, obstetri more...
Dufner Instrumente GmbH | Address: Föhrenstraße 9, Tuttlingen 78532, Germany
www.dufner-tuttlingen.de | Send Inquiry | Phone: +49-(7461)-3697
FDA Registration: 9612278
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Dufner Instrumente GmbH is a manufacturer of surgical instruments. We manufacture various laparoscopy products including grasping forceps, scissors, biopsy forceps, needle holders, endoscopes, light g more...
www.dufner-tuttlingen.de | Send Inquiry | Phone: +49-(7461)-3697
FDA Registration: 9612278
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Dufner Instrumente GmbH is a manufacturer of surgical instruments. We manufacture various laparoscopy products including grasping forceps, scissors, biopsy forceps, needle holders, endoscopes, light g more...
Dimeda Instrumente Gmbh | Address: Gansacker 54+58, Tuttlingen 78532, Germany
www.dimeda.de | Send Inquiry | Phone: +49-(7462)-94-61-0
FDA Registration: 9611283 Year Established: 1976
Products: Obstetrical Forceps (FDA Code: HDA), Aneurysm Clip Applier (FDA Code: HCI), Micro Ophthalmic Scissors, Adjustable Frequency Tuning Fork, Aluminium Tuning Fork, Ophthalmic Suture Scissors (FDA Code: HNF), ...
Dimeda Instrumente Gmbh specializes in surgical instruments. We offer products for endoscopy, neurosurgery, cardiovascular surgery, gynecology, orthopedics and plastic surgery. Our product list compri more...
www.dimeda.de | Send Inquiry | Phone: +49-(7462)-94-61-0
FDA Registration: 9611283 Year Established: 1976
Products: Obstetrical Forceps (FDA Code: HDA), Aneurysm Clip Applier (FDA Code: HCI), Micro Ophthalmic Scissors, Adjustable Frequency Tuning Fork, Aluminium Tuning Fork, Ophthalmic Suture Scissors (FDA Code: HNF), ...
Dimeda Instrumente Gmbh specializes in surgical instruments. We offer products for endoscopy, neurosurgery, cardiovascular surgery, gynecology, orthopedics and plastic surgery. Our product list compri more...
Stuckenbrock Medizintechnik Gmbh | Address: Lessingstr. 50, Tuttlingen D-78532, Germany
www.stuckenbrock.de | Send Inquiry | Phone: +49-(7461)-165880
FDA Registration: 9681452 Year Established: 1990 Quality: DIN/EN/ISO 9001, EN 46001 Certified
Products: Child Ear Curette, Uterine Curettes (FDA Code: HCY), Angular Ear Curette, Nasal Rasps (FDA Code: KBA), Straight Uterine Curette w/Regular Tip, Buck Ear Curettes, ...
Stuckenbrock Medizintechnik Gmbh specializes in orthopedic implants, instruments & prosthesis for the wrist, electrosurgical instruments, scapel blades & disposable scalpels and surgical instruments. more...
www.stuckenbrock.de | Send Inquiry | Phone: +49-(7461)-165880
FDA Registration: 9681452 Year Established: 1990 Quality: DIN/EN/ISO 9001, EN 46001 Certified
Products: Child Ear Curette, Uterine Curettes (FDA Code: HCY), Angular Ear Curette, Nasal Rasps (FDA Code: KBA), Straight Uterine Curette w/Regular Tip, Buck Ear Curettes, ...
Stuckenbrock Medizintechnik Gmbh specializes in orthopedic implants, instruments & prosthesis for the wrist, electrosurgical instruments, scapel blades & disposable scalpels and surgical instruments. more...
Gebrüder Martin GmbH & Co. KG, | Address: Ludwigstaler Str 132, Tuttlingen 78532, Germany
www.martin-med.com | Phone: +49-(7461)-706-343
FDA Registration: 8010168 Annual Revenues: < USD 1 Million Employee Count: ~700 Quality: ISO 9001, CE Certified
Products: Obstetrical Forceps (FDA Code: HDA), Sinus Endoscopy, Ethmoid Punch, Ethmoid Curettes (FDA Code: KAO), Nasal Rasps (FDA Code: KBA), Ethmoid Punch (FDA Code: KAX), Automatic Surgical Stapler (FDA Code: GAG), ...
Gebrüder Martin GmbH & Co. KG, specializes in surgical products. Our products include surgical instruments, examination lights, & medical camera systems. Our surgical instruments are used in electrosu more...
www.martin-med.com | Phone: +49-(7461)-706-343
FDA Registration: 8010168 Annual Revenues: < USD 1 Million Employee Count: ~700 Quality: ISO 9001, CE Certified
Products: Obstetrical Forceps (FDA Code: HDA), Sinus Endoscopy, Ethmoid Punch, Ethmoid Curettes (FDA Code: KAO), Nasal Rasps (FDA Code: KBA), Ethmoid Punch (FDA Code: KAX), Automatic Surgical Stapler (FDA Code: GAG), ...
Gebrüder Martin GmbH & Co. KG, specializes in surgical products. Our products include surgical instruments, examination lights, & medical camera systems. Our surgical instruments are used in electrosu more...
Af-Instrumente | Address: Moltkestr. 52/1, Tuttlingen 78532, Germany
www.af-medical-trauma.com | Send Inquiry | Phone: +49-(7467)-9491980
Products: Orbital Implants, Supramid Sheet, Orthopedic Implants Small Fragment Sets, Orthopaedic Implants, Nail Extractors (FDA Code: HWB), Spare Hook for K Nail Extractor, Square Nail Extractor Hook, ...
Af-Instrumente manufactures orthopaedic implants. Our orthopaedic implants are used for routine trauma surgery. Our product line comprises of fragment implants, instruments and sets, cannulated screw more...
www.af-medical-trauma.com | Send Inquiry | Phone: +49-(7467)-9491980
Products: Orbital Implants, Supramid Sheet, Orthopedic Implants Small Fragment Sets, Orthopaedic Implants, Nail Extractors (FDA Code: HWB), Spare Hook for K Nail Extractor, Square Nail Extractor Hook, ...
Af-Instrumente manufactures orthopaedic implants. Our orthopaedic implants are used for routine trauma surgery. Our product line comprises of fragment implants, instruments and sets, cannulated screw more...
Medicon eG | Address: Postfach 44 55, Tuttlingen D-78509, Germany
www.medicon.de | Send Inquiry | Phone: +49-(0)-7462/20-09-0
FDA Registration: 8010099 Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Clamps, Curettes, Forceps (FDA Code: HTD), Scissors, Titanium Plating Systems, Pituitary Scoops, ...
Medicon eG specializes in the production of surgical tools. We offer a wide range of instruments for anaesthesia. Our modified magill forceps are characterised by atraumatic jaws that render safe and more...
www.medicon.de | Send Inquiry | Phone: +49-(0)-7462/20-09-0
FDA Registration: 8010099 Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Clamps, Curettes, Forceps (FDA Code: HTD), Scissors, Titanium Plating Systems, Pituitary Scoops, ...
Medicon eG specializes in the production of surgical tools. We offer a wide range of instruments for anaesthesia. Our modified magill forceps are characterised by atraumatic jaws that render safe and more...
Aesculap Ag | Address: 1120, Tuttlingen, Donau D-78532, Germany
www.aesculap.de | Send Inquiry | Phone: +94-(610)-9849074
FDA Registration: 9610612
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Laser Power Probe, Laparoscopic Probes, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ...
Aesculap Ag offers instruments for minimal invasive surgery. Our product range includes surgical instruments for open or minimally invasive approaches, implants for orthopedic, neuro and spinal surger more...
www.aesculap.de | Send Inquiry | Phone: +94-(610)-9849074
FDA Registration: 9610612
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Laser Power Probe, Laparoscopic Probes, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ...
Aesculap Ag offers instruments for minimal invasive surgery. Our product range includes surgical instruments for open or minimally invasive approaches, implants for orthopedic, neuro and spinal surger more...
Tontarra Medizintechnik Gmbh | Address: Daimlerstrasse 15, Wurmlingen, DE-BW D-78573, Germany
FDA Registration: 9680515
Products: Nasal Scissors Straight (FDA Code: KBD), Nasal Punch (FDA Code: KAY), Nasal Scissors (FDA Code: KBD), Rib Rongeurs (FDA Code: HTX), Mastoid Rongeurs (FDA Code: JZA), ENT Forceps (FDA Code: KAE), ...
Tontarra Medizintechnik Gmbh is a provider of surgical instruments. more...
FDA Registration: 9680515
Products: Nasal Scissors Straight (FDA Code: KBD), Nasal Punch (FDA Code: KAY), Nasal Scissors (FDA Code: KBD), Rib Rongeurs (FDA Code: HTX), Mastoid Rongeurs (FDA Code: JZA), ENT Forceps (FDA Code: KAE), ...
Tontarra Medizintechnik Gmbh is a provider of surgical instruments. more...
CM Instrumente GmbH | Address: Im Gänsäcker 56, Tuttlingen, Deutschland 78532, Germany
www.cm-instrumente.de | Send Inquiry | Phone: +49-(7462)-2042070
FDA Registration: 9680518
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Laser Power Probe, Laparoscopic Probes, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ...
Cm Instrumente Gmbh is a manufacturer and distributor of surgical instruments & surgical implants. Our surgical instruments include osteosynthesis, aluminum rib spreaders, atraumatic cardiovascular cl more...
www.cm-instrumente.de | Send Inquiry | Phone: +49-(7462)-2042070
FDA Registration: 9680518
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Laser Power Probe, Laparoscopic Probes, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ...
Cm Instrumente Gmbh is a manufacturer and distributor of surgical instruments & surgical implants. Our surgical instruments include osteosynthesis, aluminum rib spreaders, atraumatic cardiovascular cl more...
Geister Medizintechnik GmbH | Address: Föhrenstrasse 2, Tuttlingen D-78532, Germany
www.geister.com | Send Inquiry | Phone: +49-(7461)-966240
FDA Registration: 8010697 Quality: DIN ISO 9001, ISO 13485 Certified
Products: Anastomosis Clamps, Abdominal Retractor, Aluminium Retractors, Atrial Retractors, Adventitia Scissors, Abdominal Frame Retractor System, ...
Geister Medizintechnik GmbH is a manufacturer of specialized surgical products carrying a full range of advanced surgical instruments and devices. We work in the three business fields such as cardio, more...
www.geister.com | Send Inquiry | Phone: +49-(7461)-966240
FDA Registration: 8010697 Quality: DIN ISO 9001, ISO 13485 Certified
Products: Anastomosis Clamps, Abdominal Retractor, Aluminium Retractors, Atrial Retractors, Adventitia Scissors, Abdominal Frame Retractor System, ...
Geister Medizintechnik GmbH is a manufacturer of specialized surgical products carrying a full range of advanced surgical instruments and devices. We work in the three business fields such as cardio, more...
Tekno-medical Optik-Chirurgie GmbH & Co KG. | Address: Sattlerstrasse 11, Tuttlingen D-78532, Germany
www.tekno-medical.com | Send Inquiry | Phone: +49-(7461)-1701-0
Annual Revenues: USD 5-10 Million Employee Count: ~50 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Kerrison Punches, Laryngeal Mirrors, Nasal & Ear Specula, Biopsy Forceps, Internal Jugular Approach 7, Alligator Forceps, ...
Tekno-medical Optik-Chirurgie GmbH & Co KG. specializes in surgery, endoscopy, ENT, H-F surgery, and dental instruments. We also focus on the supply of different medical articles. Our product catalogu more...
www.tekno-medical.com | Send Inquiry | Phone: +49-(7461)-1701-0
Annual Revenues: USD 5-10 Million Employee Count: ~50 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Kerrison Punches, Laryngeal Mirrors, Nasal & Ear Specula, Biopsy Forceps, Internal Jugular Approach 7, Alligator Forceps, ...
Tekno-medical Optik-Chirurgie GmbH & Co KG. specializes in surgery, endoscopy, ENT, H-F surgery, and dental instruments. We also focus on the supply of different medical articles. Our product catalogu more...
Allegiance Healthcare Corp. | Address: Zona Franca Las Americas, Autlas Americas Km 22 1-2 Sur, Santo Domingo, Dominican Republic
Phone: 847-473-1500
FDA Registration: 9680904
Products: Biopsy Instruments (FDA Code: KNW), Biopsy Instruments (FDA Code: KNW), Catheter Needle (FDA Code: GCB), Surgical Needle Guide (FDA Code: GDF), Amniotic Fluid Sampler (FDA Code: HIO), Biopsy Needle Kit (FDA Code: FCG), ...
Allegiance Healthcare Corp are providers of introducer needle reusables, disposable bome marrow biopsy needles and trays. more...
Phone: 847-473-1500
FDA Registration: 9680904
Products: Biopsy Instruments (FDA Code: KNW), Biopsy Instruments (FDA Code: KNW), Catheter Needle (FDA Code: GCB), Surgical Needle Guide (FDA Code: GDF), Amniotic Fluid Sampler (FDA Code: HIO), Biopsy Needle Kit (FDA Code: FCG), ...
Allegiance Healthcare Corp are providers of introducer needle reusables, disposable bome marrow biopsy needles and trays. more...
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FDA Code / Regulation: GAI / 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.
