General & Plastic Surgery Forceps Suppliers
Limit companies to: Worldwide USA
Marida, Marianne Daniels Chir. Instr. | Address: Doenhoffstrasse 6, Solingen 42655, Germany 
Phone: +49-(212)-81 22 25
FDA Registration: 9680059
Products: General use Surgical Curettes (FDA Code: FZS), Surgical Curette (FDA Code: FZS), Chisel/Osteotome (FDA Code: KDG), General & Plastic Surgery Surgical Clamp (FDA Code: GDJ), General Surgical Scissors (FDA Code: LRW), Calipers (FDA Code: KTZ), ...
Marida, Marianne Daniels Chir. Instr. deals with surgical scissors, needle holder, surgical clamp and various plastic surgery products. more...
Phone: +49-(212)-81 22 25
FDA Registration: 9680059
Products: General use Surgical Curettes (FDA Code: FZS), Surgical Curette (FDA Code: FZS), Chisel/Osteotome (FDA Code: KDG), General & Plastic Surgery Surgical Clamp (FDA Code: GDJ), General Surgical Scissors (FDA Code: LRW), Calipers (FDA Code: KTZ), ...
Marida, Marianne Daniels Chir. Instr. deals with surgical scissors, needle holder, surgical clamp and various plastic surgery products. more...
Gustav Weck | Address: Lohdorfer Str. 187a, Solingen D-42699, Germany
www.gustav-weck-solingen.de | Send Inquiry | Phone: +49-(212)-62219
Annual Revenues: < USD 1 Million Quality: ISO 9002, CE Certified
Products: Cosmetic Microsurgical Instruments, Titanium Microsurgical Instruments, Microsurgical Instruments (FDA Code: GZX), Y-Stent Forceps, ENT Forceps (FDA Code: KAE), Artery Vascular Clamp (FDA Code: DXC), ...
Gustav Weck is a manufacturer of surgical instruments. more...
www.gustav-weck-solingen.de | Send Inquiry | Phone: +49-(212)-62219
Annual Revenues: < USD 1 Million Quality: ISO 9002, CE Certified
Products: Cosmetic Microsurgical Instruments, Titanium Microsurgical Instruments, Microsurgical Instruments (FDA Code: GZX), Y-Stent Forceps, ENT Forceps (FDA Code: KAE), Artery Vascular Clamp (FDA Code: DXC), ...
Gustav Weck is a manufacturer of surgical instruments. more...
Witte Gmbh | Address: Mankhauser Str. 1, Solingen 42699, Germany
www.witte24.de | Send Inquiry | Phone: +49-(212)-331077
Year Established: 1883 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9002, CE Certified
Products: Obstetrical Forceps (FDA Code: HDA), Nail Extractors (FDA Code: HWB), Spare Hook for K Nail Extractor, Square Nail Extractor Hook, Baby Ear Syringe, ENT Irrigation Syringe (FDA Code: KCP), ...
Witte Gmbh manufactures surgical instruments. Our product list comprises of scissors, clamps, tweezers, needle holders, and self retaining retractors. Our reflex hammer has two equal sized rubber head more...
www.witte24.de | Send Inquiry | Phone: +49-(212)-331077
Year Established: 1883 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9002, CE Certified
Products: Obstetrical Forceps (FDA Code: HDA), Nail Extractors (FDA Code: HWB), Spare Hook for K Nail Extractor, Square Nail Extractor Hook, Baby Ear Syringe, ENT Irrigation Syringe (FDA Code: KCP), ...
Witte Gmbh manufactures surgical instruments. Our product list comprises of scissors, clamps, tweezers, needle holders, and self retaining retractors. Our reflex hammer has two equal sized rubber head more...
Friedrich Daniels Gmbh | Address: Donhoffstr. 6, Solingen 42655, Germany
www.friedrich-daniels.com | Send Inquiry | Phone: +49-(212)-810050
FDA Registration: 9611390
Products: Blood Collection Sets with Needle Holder, Blood Needle Holder Systems, Artery Vascular Clamp (FDA Code: DXC), Bending/Contouring Instrument (FDA Code: HXP), Bone Skid (FDA Code: HWO), Bladder Neck Spreader (FDA Code: FHK), ...
Friedrich Daniels Gmbh specializes in surgical instruments. Our surgical instruments include bone probes, modular spine distractor, bone cutting instruments, elevators, soft grip rongeurs, punches, so more...
www.friedrich-daniels.com | Send Inquiry | Phone: +49-(212)-810050
FDA Registration: 9611390
Products: Blood Collection Sets with Needle Holder, Blood Needle Holder Systems, Artery Vascular Clamp (FDA Code: DXC), Bending/Contouring Instrument (FDA Code: HXP), Bone Skid (FDA Code: HWO), Bladder Neck Spreader (FDA Code: FHK), ...
Friedrich Daniels Gmbh specializes in surgical instruments. Our surgical instruments include bone probes, modular spine distractor, bone cutting instruments, elevators, soft grip rongeurs, punches, so more...
Hammacher Instrumente Gmbh | Address: Steinendorfer Str. 27, Solingen 42699, Germany
www.hammacher.de | Send Inquiry | Phone: +49-(212)-262500
Annual Revenues: < USD 1 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Absorbable Suture Anchors, Absorbable Sutures (FDA Code: GAK), Adenoid Curettes (FDA Code: KBJ), Adenoid Punches (FDA Code: KBS), Absorbable Suture Screwed Anchor, Adult Tongue Depressor (FDA Code: FMA), ...
Hammacher Instrumente Gmbh is a manufacturer of stainless steel wironit instruments for dental, biological and medical laboratories. Our dental products include impression trays, whetstones, surgical more...
www.hammacher.de | Send Inquiry | Phone: +49-(212)-262500
Annual Revenues: < USD 1 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Absorbable Suture Anchors, Absorbable Sutures (FDA Code: GAK), Adenoid Curettes (FDA Code: KBJ), Adenoid Punches (FDA Code: KBS), Absorbable Suture Screwed Anchor, Adult Tongue Depressor (FDA Code: FMA), ...
Hammacher Instrumente Gmbh is a manufacturer of stainless steel wironit instruments for dental, biological and medical laboratories. Our dental products include impression trays, whetstones, surgical more...
Koscher & Wurtz Gmbh | Address: Chirurgische Instrumente, Einsteinstr. 7, Spaichingen 78549, Germany
www.koscher-wuertz.de | Send Inquiry | Phone: +49-(7424)-958-300
FDA Registration: 8010877
Products: Self-Retaining Retractors (FDA Code: FFO), Self-Retaining Retractor Systems, Knee Self-Retaining Retractors, Angular Ear Curette, Rectal Speculums, Rectal Speculums (FDA Code: FFQ), ...
Koscher & Wurtz Gmbh specializes in surgical instruments. Our product list comprises of surgical/gynecological forceps, trocars & cannulas, retractors, articulators and hysteroscopic accessories. more...
www.koscher-wuertz.de | Send Inquiry | Phone: +49-(7424)-958-300
FDA Registration: 8010877
Products: Self-Retaining Retractors (FDA Code: FFO), Self-Retaining Retractor Systems, Knee Self-Retaining Retractors, Angular Ear Curette, Rectal Speculums, Rectal Speculums (FDA Code: FFQ), ...
Koscher & Wurtz Gmbh specializes in surgical instruments. Our product list comprises of surgical/gynecological forceps, trocars & cannulas, retractors, articulators and hysteroscopic accessories. more...
Manogg Medizintechnik | Address: Alemannen-Str. 3, Stockach 78333, Germany
www.manogg.de | Send Inquiry | Phone: +49-(7771)-920-386
FDA Registration: 8010234 Quality: ISO 9001, CE Certified
Products: Bone Rongeurs, Bone Holding Forceps, Abnominal Retractors, Bone Cutting Forceps, Cartilage Clamp, Abdominal Retractor, ...
Manogg Medizintechnik provides surgical instruments. We are certified by the DIN ISO 9001 / EN 46001 norm. Our product line comprises of bone cutting forceps, bone holding forceps, abdominal retractor more...
www.manogg.de | Send Inquiry | Phone: +49-(7771)-920-386
FDA Registration: 8010234 Quality: ISO 9001, CE Certified
Products: Bone Rongeurs, Bone Holding Forceps, Abnominal Retractors, Bone Cutting Forceps, Cartilage Clamp, Abdominal Retractor, ...
Manogg Medizintechnik provides surgical instruments. We are certified by the DIN ISO 9001 / EN 46001 norm. Our product line comprises of bone cutting forceps, bone holding forceps, abdominal retractor more...
Stema Medizintechnik Gmbh | Address: Talstr. 5a, Stockach 78333, Germany
www.stema-medizintechnik.net | Send Inquiry | Phone: +49-(0)-77 71-875 351
FDA Registration: 3004705187 Quality: ISO 9001:2003 Certified
Products: Guiding Probes, General use Surgical Curettes (FDA Code: FZS), General & Plastic Surgery Forceps (FDA Code: GEN), General & Plastic Surgery Surgical Cannula (FDA Code: GEA), General Surgical Manual Instrument (FDA Code: MDM), ENT Trocar (FDA Code: KTE), ...
Stema Medizintechnik Gmbh deals with surgical products. Our products are used for arthroscopy, bronchoscopy, ENT, gastro-intestinal applications, gynecology, HF surgery, laparoscopy, OMF-surgery, and more...
www.stema-medizintechnik.net | Send Inquiry | Phone: +49-(0)-77 71-875 351
FDA Registration: 3004705187 Quality: ISO 9001:2003 Certified
Products: Guiding Probes, General use Surgical Curettes (FDA Code: FZS), General & Plastic Surgery Forceps (FDA Code: GEN), General & Plastic Surgery Surgical Cannula (FDA Code: GEA), General Surgical Manual Instrument (FDA Code: MDM), ENT Trocar (FDA Code: KTE), ...
Stema Medizintechnik Gmbh deals with surgical products. Our products are used for arthroscopy, bronchoscopy, ENT, gastro-intestinal applications, gynecology, HF surgery, laparoscopy, OMF-surgery, and more...
Waldemar Krotz | Address: Tuttlinger Str. 7, Talheim 78607, Germany
Phone: +49-(7461)-1247
Products: Obstetrical Forceps (FDA Code: HDA), Bone Clamp (FDA Code: HXD), General & Plastic Surgery Forceps (FDA Code: GEN), ...
Waldemar Krotz specializes in offering general & plastic surgery instruments. Our products include general & plastic surgery surgical forceps, bone clamps, and obstetrical forceps. more...
Phone: +49-(7461)-1247
Products: Obstetrical Forceps (FDA Code: HDA), Bone Clamp (FDA Code: HXD), General & Plastic Surgery Forceps (FDA Code: GEN), ...
Waldemar Krotz specializes in offering general & plastic surgery instruments. Our products include general & plastic surgery surgical forceps, bone clamps, and obstetrical forceps. more...
Bissinger Guenter, Medizintechnik Gmbh | Address: Hans-Theisen-Str. 1, Teningen 79331, Germany
bissinger.com | Send Inquiry | Phone: +49-(7461)-9 14 33-0
FDA Registration: 8010456 Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Cosmetic Microsurgical Instruments, Ophthalmic Suture Scissors (FDA Code: HNF), Ophthalmic Forceps (FDA Code: HNR), Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), Bipolar Endoscopic Coagulator-Cutter and Accessories (FDA Code: HIN), Endoscopic Electrosurgical Unit and Accessories (FDA Code: KNS), ...
Bissinger Guenter, Medizintechnik Gmbh specializes in medical instruments. Our bipolar instruments include forceps, scissors, and clamp scissor. We offer bipolar and monopolar connecting cables for ma more...
bissinger.com | Send Inquiry | Phone: +49-(7461)-9 14 33-0
FDA Registration: 8010456 Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Cosmetic Microsurgical Instruments, Ophthalmic Suture Scissors (FDA Code: HNF), Ophthalmic Forceps (FDA Code: HNR), Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), Bipolar Endoscopic Coagulator-Cutter and Accessories (FDA Code: HIN), Endoscopic Electrosurgical Unit and Accessories (FDA Code: KNS), ...
Bissinger Guenter, Medizintechnik Gmbh specializes in medical instruments. Our bipolar instruments include forceps, scissors, and clamp scissor. We offer bipolar and monopolar connecting cables for ma more...
Tuebingen Scientific Medical Gmbh | Address: Dorfackerstrasse 26, Tuebingen 72074, Germany
www.tuebingen-scientific.com | Send Inquiry | Phone: +49-(7071)-77 04-5 18
Products: Surgical Retractor Systems (FDA Code: GAD), Surgical Retractor (FDA Code: GAD), General & Plastic Surgery Forceps (FDA Code: GEN), Surgical Needle Guide (FDA Code: GDF), ...
Tuebingen Scientific Medical Gmbh develops, produces and markets instruments & accessories for surgery. Our radius surgical system is a natural extension that emulates the instinctive movement of hand more...
www.tuebingen-scientific.com | Send Inquiry | Phone: +49-(7071)-77 04-5 18
Products: Surgical Retractor Systems (FDA Code: GAD), Surgical Retractor (FDA Code: GAD), General & Plastic Surgery Forceps (FDA Code: GEN), Surgical Needle Guide (FDA Code: GDF), ...
Tuebingen Scientific Medical Gmbh develops, produces and markets instruments & accessories for surgery. Our radius surgical system is a natural extension that emulates the instinctive movement of hand 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...
Gonzalez Surgical Instruments | Address: Olgastrasse 27, Tuttlingen 78532, Germany
Phone: +49-(7461)-7801726
Products: Ear Knife (FDA Code: JYO), Dermatomes (FDA Code: GFD), General & Plastic Surgery Surgical Gouge (FDA Code: GDH), General & Plastic Surgery Surgical Mallet (FDA Code: GFJ), Reusable Suture Needle (FDA Code: GDL), Impactor (FDA Code: HWA), ...
Gonzalez Surgical Instruments offers scalpel handles, skin markers, spatulas, dissectors for general & plastic surgery, elevators and forceps. We also supply surgical rasps, nasal chisels, retractors, more...
Phone: +49-(7461)-7801726
Products: Ear Knife (FDA Code: JYO), Dermatomes (FDA Code: GFD), General & Plastic Surgery Surgical Gouge (FDA Code: GDH), General & Plastic Surgery Surgical Mallet (FDA Code: GFJ), Reusable Suture Needle (FDA Code: GDL), Impactor (FDA Code: HWA), ...
Gonzalez Surgical Instruments offers scalpel handles, skin markers, spatulas, dissectors for general & plastic surgery, elevators and forceps. We also supply surgical rasps, nasal chisels, retractors, more...
Normed Gmbh | Address: Ulrichstr. 7, Tuttlingen 78532, Germany
www.normed-online.com | Send Inquiry | Phone: +49-(7461)-9343-0
Quality: CE mark 0123 ISO 13485 : 2003 and DIN EN 46001 Certified
Products: Stainless Steel Surgical Wire, Cardiovascular Surgical Instrument (FDA Code: DWS), Surgical Wire (FDA Code: LRN), General & Plastic Surgery Forceps (FDA Code: GEN), General & Plastic Surgery Surgical Clamp (FDA Code: GDJ), General & Plastic Surgery Surgical Gouge (FDA Code: GDH), ...
Normed Gmbh is a manufacturer of medical devices. We offer orthopedic, hand, neuro, foot or ankle, cranio-maxillo-facial surgery and ascension products. Our external fixator modular systems cover all more...
www.normed-online.com | Send Inquiry | Phone: +49-(7461)-9343-0
Quality: CE mark 0123 ISO 13485 : 2003 and DIN EN 46001 Certified
Products: Stainless Steel Surgical Wire, Cardiovascular Surgical Instrument (FDA Code: DWS), Surgical Wire (FDA Code: LRN), General & Plastic Surgery Forceps (FDA Code: GEN), General & Plastic Surgery Surgical Clamp (FDA Code: GDJ), General & Plastic Surgery Surgical Gouge (FDA Code: GDH), ...
Normed Gmbh is a manufacturer of medical devices. We offer orthopedic, hand, neuro, foot or ankle, cranio-maxillo-facial surgery and ascension products. Our external fixator modular systems cover all more...
Bontempi Chirurgische Instrumente Ohg | Address: Bodenseestr. 1, Tuttlingen 78532, Germany
Phone: +49-(7461)-966750
FDA Registration: 9615835
Products: Wire Cutters (FDA Code: HXZ), Nasal Chisel (FDA Code: KAN), Rib Rongeurs (FDA Code: HTX), General & Plastic Surgery Surgical Dissector (FDA Code: GDI), Surgical Orthopedic Scissors (FDA Code: HRR), Surgical Pliers (FDA Code: HTC), ...
Bontempi Chirurgische Instrumente Ohg provides surgical pliers, wire cutters, scissors and rongeurs. more...
Phone: +49-(7461)-966750
FDA Registration: 9615835
Products: Wire Cutters (FDA Code: HXZ), Nasal Chisel (FDA Code: KAN), Rib Rongeurs (FDA Code: HTX), General & Plastic Surgery Surgical Dissector (FDA Code: GDI), Surgical Orthopedic Scissors (FDA Code: HRR), Surgical Pliers (FDA Code: HTC), ...
Bontempi Chirurgische Instrumente Ohg provides surgical pliers, wire cutters, scissors and rongeurs. more...
August Reuchlen GmbH | Address: Junkersstr 8, Tuttlingen 78532, Germany
www.reuchlen.com | Send Inquiry | Phone: +49-(7461)-9652-0
FDA Registration: 8010303 Employee Count: ~50 Quality: ISO 9001, CE Certified
Products: Forceps Needle Holders, Cosmetic Microsurgical Instruments, Titanium Microsurgical Instruments, Microsurgical Instruments (FDA Code: GZX), Renal & Carotid Artery Clamps, Carotid Artery Clamp (FDA Code: HCE), ...
August Reuchlen GmbH is a manufacturer of surgical instruments and implants. more...
www.reuchlen.com | Send Inquiry | Phone: +49-(7461)-9652-0
FDA Registration: 8010303 Employee Count: ~50 Quality: ISO 9001, CE Certified
Products: Forceps Needle Holders, Cosmetic Microsurgical Instruments, Titanium Microsurgical Instruments, Microsurgical Instruments (FDA Code: GZX), Renal & Carotid Artery Clamps, Carotid Artery Clamp (FDA Code: HCE), ...
August Reuchlen GmbH is a manufacturer of surgical instruments and implants. more...
Stephan Schilling GmbH | Address: Uhlandstr 17/1, Tuttlingen D-78532, Germany
Phone: +49-(7461)-2887
Employee Count: ~20
Products: Aorta Clamp, Spoon-shaped Jaws, Aorta Clamp, Cosmetic Microsurgical Instruments, Titanium Microsurgical Instruments, Microsurgical Instruments (FDA Code: GZX), Ascending Aorta Clamps, ...
Stephan Schilling GmbH deals with general & plastic surgery forceps, surgical clamps and vascular clamps. more...
Phone: +49-(7461)-2887
Employee Count: ~20
Products: Aorta Clamp, Spoon-shaped Jaws, Aorta Clamp, Cosmetic Microsurgical Instruments, Titanium Microsurgical Instruments, Microsurgical Instruments (FDA Code: GZX), Ascending Aorta Clamps, ...
Stephan Schilling GmbH deals with general & plastic surgery forceps, surgical clamps and vascular clamps. more...
Manfred Hilzinger KG | Address: Gänsäcker 50, Tuttlingen 78532, Germany
www.mhi-hilzinger.de | Send Inquiry | Phone: +49-(07462)-7592
FDA Registration: 8010534 Year Established: 1980 Quality: ISO 9001/EN 46001 Certified
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Forceps Needle Holders, Micro Needle Holder, Hexagonal Needle Holder, Y-Stent Forceps, ENT Forceps (FDA Code: KAE), ...
Manfred Hilzinger KG manufactures surgical instruments for the medical field. We distribute medical instruments & equipment, and measurement technology. more...
www.mhi-hilzinger.de | Send Inquiry | Phone: +49-(07462)-7592
FDA Registration: 8010534 Year Established: 1980 Quality: ISO 9001/EN 46001 Certified
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Forceps Needle Holders, Micro Needle Holder, Hexagonal Needle Holder, Y-Stent Forceps, ENT Forceps (FDA Code: KAE), ...
Manfred Hilzinger KG manufactures surgical instruments for the medical field. We distribute medical instruments & equipment, and measurement technology. more...
Instrumed GmbH | Address: 3 Unter Buchsteig, Tuttlingen 78532, Germany
Phone: +49-(7462)-20049-126
FDA Registration: 8010372 Employee Count: ~10
Products: Ear Knife (FDA Code: JYO), Laser Power Probe, Laparoscopic Probes, Guiding Probes, General & Plastic Surgery Surgical Hook (FDA Code: GDG), ENT Elevator (FDA Code: KAD), ...
Instrumed GmbH deals with vaginal retractors, self-retaining retractors, ophthalmic rings, ronguers, ENT knives and hemostats. more...
Phone: +49-(7462)-20049-126
FDA Registration: 8010372 Employee Count: ~10
Products: Ear Knife (FDA Code: JYO), Laser Power Probe, Laparoscopic Probes, Guiding Probes, General & Plastic Surgery Surgical Hook (FDA Code: GDG), ENT Elevator (FDA Code: KAD), ...
Instrumed GmbH deals with vaginal retractors, self-retaining retractors, ophthalmic rings, ronguers, ENT knives and hemostats. more...
Anton Keller Inh. Willy Keller Chirurg. Instrument | Address: Junkerstr. 2, Tuttlingen 78532, Germany
Products: General & Plastic Surgery Forceps (FDA Code: GEN), ...
Anton Keller Inh. Willy Keller Chirurg. Instrument provides forceps for use in general & plastic surgery. more...
Products: General & Plastic Surgery Forceps (FDA Code: GEN), ...
Anton Keller Inh. Willy Keller Chirurg. Instrument provides forceps for use in general & plastic surgery. more...
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FDA Code / Regulation: GEN / 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.
