Surgical Cutter Suppliers
Limit companies to: Worldwide USA
Swann-morton Limited | Address: Owlerton Green, Sheffield, England S6 2BJ, United Kingdom 
www.swann-morton.com | Send Inquiry | Phone: +44-(114)-234 4223
FDA Registration: 9611194 Year Established: 1932 Annual Revenues: USD 25-50 Million Employee Count: ~300 Quality: ISO 9001, ISO 9002, CE Certified
Products: Sickle Blades, Skin Grafting Instruments, Surgical Blades, Surgical Blade Handles, Scalpel Handle (FDA Code: GDZ), Surgical Equipment, Blades & Burrs, ...
Swann-morton Limited supplies surgical blades and handles for surgeons & health care professionals. We are an ISO certified company. Our blades can be used in minor surgery, oral surgery, implantology more...
www.swann-morton.com | Send Inquiry | Phone: +44-(114)-234 4223
FDA Registration: 9611194 Year Established: 1932 Annual Revenues: USD 25-50 Million Employee Count: ~300 Quality: ISO 9001, ISO 9002, CE Certified
Products: Sickle Blades, Skin Grafting Instruments, Surgical Blades, Surgical Blade Handles, Scalpel Handle (FDA Code: GDZ), Surgical Equipment, Blades & Burrs, ...
Swann-morton Limited supplies surgical blades and handles for surgeons & health care professionals. We are an ISO certified company. Our blades can be used in minor surgery, oral surgery, implantology more...
Timesco | Address: Timesco House, 3 Carnival Park, Carnival Close, Basildon, Essex SS14 3WN, United Kingdom
www.timesco.com | Send Inquiry | Phone: +44-(1268)-297-710
FDA Registration: 8021788 Annual Revenues: < USD 1 Million Employee Count: ~20 Quality: ISO 9002, CE Certified
Products: Laryngoscopes, Dressing Forceps, Castroviejo Corneal Scissors, Jewelers Bipolar Forceps, Stevens Tenotomy Scissors, Enucleation Scissors, ...
Timesco produces and markets theatre quality surgical instruments. We also deal with allied surgical and medical products for other medical fields. Our product line includes anesthetic, foot care, sur more...
www.timesco.com | Send Inquiry | Phone: +44-(1268)-297-710
FDA Registration: 8021788 Annual Revenues: < USD 1 Million Employee Count: ~20 Quality: ISO 9002, CE Certified
Products: Laryngoscopes, Dressing Forceps, Castroviejo Corneal Scissors, Jewelers Bipolar Forceps, Stevens Tenotomy Scissors, Enucleation Scissors, ...
Timesco produces and markets theatre quality surgical instruments. We also deal with allied surgical and medical products for other medical fields. Our product line includes anesthetic, foot care, sur more...
Allegiance Healthcare (thailand) Limited | Address: 7/111 Moo 4 Highway# 331, Mabyangporn, Pluakdaeng, Rayong 21140, Thailand
Send Inquiry | Phone: +66-(38)-956-155-62
FDA Registration: 9615914
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Arthroscopes (FDA Code: HRX), Surgical Drapes & Packs (FDA Code: KKX), Catheter Accessories (FDA Code: KGZ), ...
Allegiance Healthcare (Thailand) Limited, is a manufacturer of surgical and medical gloves. more...
Send Inquiry | Phone: +66-(38)-956-155-62
FDA Registration: 9615914
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Arthroscopes (FDA Code: HRX), Surgical Drapes & Packs (FDA Code: KKX), Catheter Accessories (FDA Code: KGZ), ...
Allegiance Healthcare (Thailand) Limited, is a manufacturer of surgical and medical gloves. more...
Synthes Gmbh | Address: Eimattstrasse 3, Oberdorf CH-4436, Switzerland
www.synthes.com | Send Inquiry | Phone: +41-(61)-9656666
FDA Registration: 8030965
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Surgical Retractor Systems (FDA Code: GAD), ...
Synthes GmbH develops, produces and markets instruments, implants & biomaterials for the surgical fixation, correction & regeneration of the skeleton & its soft tissues. Trauma implants and instrument more...
www.synthes.com | Send Inquiry | Phone: +41-(61)-9656666
FDA Registration: 8030965
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Surgical Retractor Systems (FDA Code: GAD), ...
Synthes GmbH develops, produces and markets instruments, implants & biomaterials for the surgical fixation, correction & regeneration of the skeleton & its soft tissues. Trauma implants and instrument more...
Zimmer Gmbh | Address: Sulzer Allee 8, Winterthur CH-8404, Switzerland
FDA Registration: 9613350
Products: Forceps (FDA Code: HTD), 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), ...
Zimmer Gmbh designs and manufactures reconstructive spinal and dental implants, trauma and related orthopedic surgical products. We also offer joint replacement solutions for knee pain and hip pain, a more...
FDA Registration: 9613350
Products: Forceps (FDA Code: HTD), 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), ...
Zimmer Gmbh designs and manufactures reconstructive spinal and dental implants, trauma and related orthopedic surgical products. We also offer joint replacement solutions for knee pain and hip pain, a more...
OAO Kazan Medical Instruments Factory | Address: 12 Salih Sajdasheva, Kazan, Tatarstan 420021, Russian Federation
www.kmizmarket.ru | Send Inquiry | Phone: +7-(843)-221-93-22
Quality: ISO 9001:2000,ISO 13845:2003 Certified
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Surgical Retractor Systems (FDA Code: GAD), Lacrimal Dilator (FDA Code: HNW), Scalpel Handle (FDA Code: GDZ), ...
OAO Kazan Medical Instruments Factory is a manufacturer of dental instruments, general surgery instruments, microsurgical instruments & kits and polymer tools. We also offer products for urology, gyne more...
www.kmizmarket.ru | Send Inquiry | Phone: +7-(843)-221-93-22
Quality: ISO 9001:2000,ISO 13845:2003 Certified
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Surgical Retractor Systems (FDA Code: GAD), Lacrimal Dilator (FDA Code: HNW), Scalpel Handle (FDA Code: GDZ), ...
OAO Kazan Medical Instruments Factory is a manufacturer of dental instruments, general surgery instruments, microsurgical instruments & kits and polymer tools. We also offer products for urology, gyne more...
Chifa Sp. Z.o.o. | Address: Ul. Tysiaclecia, Nowy Tomysl, Poland
Phone: +48-(61)-4420100
FDA Registration: 9680260
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Forceps Needle Holders, Stainless Steel Needle Holders, Tungsten Carbide Needle Holders, Micro Needle Holder, ...
Chifa Sp. Z.o.o. specializes in offering surgical products. We offer ligature carriers, surgical clamps, dental scissors, crown scissors, dental elevators, ophthalmic forceps, needle holders, orthodon more...
Phone: +48-(61)-4420100
FDA Registration: 9680260
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Forceps Needle Holders, Stainless Steel Needle Holders, Tungsten Carbide Needle Holders, Micro Needle Holder, ...
Chifa Sp. Z.o.o. specializes in offering surgical products. We offer ligature carriers, surgical clamps, dental scissors, crown scissors, dental elevators, ophthalmic forceps, needle holders, orthodon more...
Accuray Surgicals Ltd. | Address: Lakson Square Bldg. #2, Sarwar Shaheed Rd., Karachi 74200, Pakistan
www.accuray.com.pk | Send Inquiry | Phone: +92-(21)-5681419
FDA Registration: 8040265 Year Established: 1981 Quality: ISO 9001:2000, ISO 13485:2003, CE Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Self-Retaining Retractors (FDA Code: FFO), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), ...
Accuray Surgicals Ltd. deals with the manufacturing of surgical, dental and veterinary instruments. Our product list comprises of operating scissors, bandage scissors, thumb dressing forceps, retracto more...
www.accuray.com.pk | Send Inquiry | Phone: +92-(21)-5681419
FDA Registration: 8040265 Year Established: 1981 Quality: ISO 9001:2000, ISO 13485:2003, CE Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Self-Retaining Retractors (FDA Code: FFO), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), ...
Accuray Surgicals Ltd. deals with the manufacturing of surgical, dental and veterinary instruments. Our product list comprises of operating scissors, bandage scissors, thumb dressing forceps, retracto more...
Chaplet Int. (Pvt.) Ltd. | Address: P.O.Box # 10039, Ferozepur Road, Lahore 54600, Pakistan
www.chapletint.com | Send Inquiry | Phone: +92-(42)-58222334
FDA Registration: 3003998824
Products: Clamps, Forceps (FDA Code: HTD), Catheter Trays, Bone Mallets (FDA Code: HXL), Stainless Steel Kidney Tray, Rib Rongeurs (FDA Code: HTX), ...
Chaplet Int. (Pvt.) Ltd. offers a comprehensive range of surgical holloware, hospital ware, surgical instruments handling and care products. Our product line comprises of wire net baskets, endoscope b more...
www.chapletint.com | Send Inquiry | Phone: +92-(42)-58222334
FDA Registration: 3003998824
Products: Clamps, Forceps (FDA Code: HTD), Catheter Trays, Bone Mallets (FDA Code: HXL), Stainless Steel Kidney Tray, Rib Rongeurs (FDA Code: HTX), ...
Chaplet Int. (Pvt.) Ltd. offers a comprehensive range of surgical holloware, hospital ware, surgical instruments handling and care products. Our product line comprises of wire net baskets, endoscope b more...
Combined Instruments (Pvt.), Ltd. | Address: 13-A Model Town, Ugoki, Sailkot, Pakistan
Phone: +92-(432)-510243
Products: Vaginal Retractors (FDA Code: HDL), Blood Lancets, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Uterine Sound Instruments, Lacrimal Dilators and Cannulas, ...
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: Vaginal Retractors (FDA Code: HDL), Blood Lancets, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Uterine Sound Instruments, Lacrimal Dilators and Cannulas, ...
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...
Everlast Surgical Co. | Address: P.o. Box 460, 460 Roras Rd., Sialkot, Pakistan
Phone: +92-(432)-561366
Products: Probes (FDA Code: HXB), Gastroenterologic Needle Holder (FDA Code: FHQ), Forceps Needle Holders, Stainless Steel Needle Holders, Tungsten Carbide Needle Holders, Micro Needle Holder, ...
Everlast Surgical Co. offers scissors, ophthalmic clamps, surgical, plastic, orthopedic holder and needle. We also offer speculum, vaginal & metal forceps for general & plastic surgery. more...
Phone: +92-(432)-561366
Products: Probes (FDA Code: HXB), Gastroenterologic Needle Holder (FDA Code: FHQ), Forceps Needle Holders, Stainless Steel Needle Holders, Tungsten Carbide Needle Holders, Micro Needle Holder, ...
Everlast Surgical Co. offers scissors, ophthalmic clamps, surgical, plastic, orthopedic holder and needle. We also offer speculum, vaginal & metal forceps for general & plastic surgery. more...
M.F. Elahi & Co. (EP) Pvt. Ltd. | Address: # 309.102.30 Wazirabad Road, Kotli Behram, Sialkot 22161, Pakistan
Phone: +92-(432)-55467
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Forceps Needle Holders, Stainless Steel Needle Holders, Tungsten Carbide Needle Holders, Micro Needle Holder, Hexagonal Needle Holder, ...
M.F. Elahi & Co. (EP) Pvt. Ltd. provides ophthalmic scissors, surgical scissors, wire cutter, forceps & retractors. We also offer needle and scalpel handles. more...
Phone: +92-(432)-55467
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Forceps Needle Holders, Stainless Steel Needle Holders, Tungsten Carbide Needle Holders, Micro Needle Holder, Hexagonal Needle Holder, ...
M.F. Elahi & Co. (EP) Pvt. Ltd. provides ophthalmic scissors, surgical scissors, wire cutter, forceps & retractors. We also offer needle and scalpel handles. more...
Spartech Instruments & Co. | Address: 60B , Small Industrial Estate, P .O. Box # 0000, Sialkot 51310, Pakistan
www.spartechinstruments.com | Send Inquiry | Phone: +92-(523)-0000000
FDA Registration: 3004892425
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Scalpel Handle (FDA Code: GDZ), Wire Cutters (FDA Code: HXZ), ...
Spartech Instruments & Co manufactures and exports surgical, dental and medical instruments. Our surgical instruments include diagnostic, anaesthesia, scalpels & knives, scissors, forceps, needle hold more...
www.spartechinstruments.com | Send Inquiry | Phone: +92-(523)-0000000
FDA Registration: 3004892425
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Scalpel Handle (FDA Code: GDZ), Wire Cutters (FDA Code: HXZ), ...
Spartech Instruments & Co manufactures and exports surgical, dental and medical instruments. Our surgical instruments include diagnostic, anaesthesia, scalpels & knives, scissors, forceps, needle hold more...
Darlyes Surgical | Address: P.O Box. 84, 2-A Kutchery Road, Sialkot, Pakistan
www.darleys-surgical.com | Send Inquiry | Phone: +92-(52)-4269230
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Retractors, Saws (FDA Code: HSO), Tissue Forceps, Suction Tubes, ...
Darlyes Surgical is engaged in the production of surgical and dental instruments. Our product line includes dressing forceps, dressing scissors, retractors, hooks, rectal speculums, scalpels & knives, more...
www.darleys-surgical.com | Send Inquiry | Phone: +92-(52)-4269230
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Retractors, Saws (FDA Code: HSO), Tissue Forceps, Suction Tubes, ...
Darlyes Surgical is engaged in the production of surgical and dental instruments. Our product line includes dressing forceps, dressing scissors, retractors, hooks, rectal speculums, scalpels & knives, more...
Saleem Surgio (regd) | Address: Karimpura Rd, Sialkot 22161, Pakistan
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Obstetrical Forceps (FDA Code: HDA), Forceps Needle Holders, Stainless Steel Needle Holders, Tungsten Carbide Needle Holders, ...
Saleem Surgio (regd) provides surgical instruments for use in general surgery, obstetrics and gynecology, orthopedics, ophthalmology, and ENT surgery. more...
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Obstetrical Forceps (FDA Code: HDA), Forceps Needle Holders, Stainless Steel Needle Holders, Tungsten Carbide Needle Holders, ...
Saleem Surgio (regd) provides surgical instruments for use in general surgery, obstetrics and gynecology, orthopedics, ophthalmology, and ENT surgery. more...
QSA Surgical (Pvt) Ltd. | Address: Ghuinke Daska Road .P.O.Box 1094, Sialkot 051310, Pakistan
Send Inquiry | Phone: +92-(432)-52 6387/6487/6587
FDA Registration: 8040233
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), Bone Hooks (FDA Code: KIK), ...
QSA Surgical (Pvt) Ltd. specializes in surgical and dental instruments. Our product line includes amalgam carvers, dental cements, dental elevators, dental waxes, orthodonic band pashers, surgical spa more...
Send Inquiry | Phone: +92-(432)-52 6387/6487/6587
FDA Registration: 8040233
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), Bone Hooks (FDA Code: KIK), ...
QSA Surgical (Pvt) Ltd. specializes in surgical and dental instruments. Our product line includes amalgam carvers, dental cements, dental elevators, dental waxes, orthodonic band pashers, surgical spa more...
Quality Concept (Pvt) Ltd. | Address: P.O. Box 2424, Small Industrial Estate, Sialkot, Pakistan
www.quality-concept.com | Send Inquiry | Phone: +92-(52)-3255528
FDA Registration: 3002090132
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), General Surgical Instruments, Instruments surgical, Surgical Retractor Systems (FDA Code: GAD), Scalpel Handle (FDA Code: GDZ), ...
Quality Concept (Pvt) Ltd. is a manufacturer and exporter of surgical, dental and laboratory instruments. Our product line includes many different kinds of patterns of precision-crafted stainless stee more...
www.quality-concept.com | Send Inquiry | Phone: +92-(52)-3255528
FDA Registration: 3002090132
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), General Surgical Instruments, Instruments surgical, Surgical Retractor Systems (FDA Code: GAD), Scalpel Handle (FDA Code: GDZ), ...
Quality Concept (Pvt) Ltd. is a manufacturer and exporter of surgical, dental and laboratory instruments. Our product line includes many different kinds of patterns of precision-crafted stainless stee more...
Micro Engineering Co. | Address: Muzaffar Pur, Ugoki Road, Sialkot, PK-PB 51310, Pakistan
www.micromanicure.com | Send Inquiry | Phone: +92-(52)-3563928
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Hooks (FDA Code: KIK), Esophageal Stethoscopes (FDA Code: BZW), Tongue Depressors (FDA Code: FMA), ...
Micro Engineering Co. is a manufacturer of surgical, dental and personal care instruments. Our surgical products include diagnostic, scissors, dissecting & tissue forceps, ligature forceps, suture, re more...
www.micromanicure.com | Send Inquiry | Phone: +92-(52)-3563928
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Hooks (FDA Code: KIK), Esophageal Stethoscopes (FDA Code: BZW), Tongue Depressors (FDA Code: FMA), ...
Micro Engineering Co. is a manufacturer of surgical, dental and personal care instruments. Our surgical products include diagnostic, scissors, dissecting & tissue forceps, ligature forceps, suture, re more...
Raiz & Sajjad Surgical (PVT) LTD. | Address: Raiz And Sajjad Surgical Pvt Ltd Jail Rd, Sialkot, PK-PB 51310, Pakistan
www.raizent.com | Send Inquiry | Phone: +92-(52)-4274284
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Trays (FDA Code: LRP), Ring Cutters (FDA Code: FNS), ...
Raiz & Sajjad Surgical (PVT) LTD. provides surgical, dental & veterinary instruments and hospital furniture. Our surgical instruments include diagnostic instruments, scapel holders, general & oprating more...
www.raizent.com | Send Inquiry | Phone: +92-(52)-4274284
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Trays (FDA Code: LRP), Ring Cutters (FDA Code: FNS), ...
Raiz & Sajjad Surgical (PVT) LTD. provides surgical, dental & veterinary instruments and hospital furniture. Our surgical instruments include diagnostic instruments, scapel holders, general & oprating more...
Clinical Surgical | Address: P.O. Gohad Pur, Near Islamia Girls High, School, Sialkot, PK-PB 51310, Pakistan
www.clinicalsurgical.com | Send Inquiry | Phone: +92-(52)-4292262
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Retractor Systems (FDA Code: GAD), Scalpel Handle (FDA Code: GDZ), ...
Clinical Surgical manufactures surgical and dental instruments. Our surgical instruments include diagnostics, anesthesia, puncture, scalpels,scissors, knives, dressing & tissue forceps, sponge and sut more...
www.clinicalsurgical.com | Send Inquiry | Phone: +92-(52)-4292262
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Retractor Systems (FDA Code: GAD), Scalpel Handle (FDA Code: GDZ), ...
Clinical Surgical manufactures surgical and dental instruments. Our surgical instruments include diagnostics, anesthesia, puncture, scalpels,scissors, knives, dressing & tissue forceps, sponge and sut more...
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FDA Code / Regulation: FZT / 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.
