Cardiovascular Biopsy Needle Suppliers
Limit companies to: Worldwide USA
Cadence Inc. | Address: 2080 Plainfield Pike, Cranston, Rhode Island 02921, USA 
www.cadenceinc.com | Send Inquiry | Phone: +1-(401)-942-1031, 800-252-3371
FDA Registration: 1213649 Year Established: 1922
Products: Anesthesia Needle Tips, Dispensing Tips, 3-Way Stop Cock, Disposable Dispensing Needle, Catheter Adaptor (FDA Code: GCE), Biopsy Needle Kit (FDA Code: FCG), ...
Cadence Inc. is a supplier of standard & customized metal tubular components, connectors, and syringes for scientific testing, sampling, diagnostic & dispensing applications. We make custom probes, ne more...
www.cadenceinc.com | Send Inquiry | Phone: +1-(401)-942-1031, 800-252-3371
FDA Registration: 1213649 Year Established: 1922
Products: Anesthesia Needle Tips, Dispensing Tips, 3-Way Stop Cock, Disposable Dispensing Needle, Catheter Adaptor (FDA Code: GCE), Biopsy Needle Kit (FDA Code: FCG), ...
Cadence Inc. is a supplier of standard & customized metal tubular components, connectors, and syringes for scientific testing, sampling, diagnostic & dispensing applications. We make custom probes, ne more...
Argon Medical Devices Inc. | Address: 1445 Flat Creek Road, Athens, Texas 75751, USA
www.argonmedical.com | Send Inquiry | Phone: +1-(903)-675-9321, 800-927-4669
FDA Registration: 1625425
Products: Irrigation Sets & Tubing, General Medical Supplies, General Surgical Instruments, General Surgery Supplies, Syringe/Needle Combos, Guide Wire Accessories, ...
Argon Medical Devices Inc. manufactures and supplies single-use vascular access devices. Our products are divided into cardiology, radiology and critical care product lines. Our products include arter more...
www.argonmedical.com | Send Inquiry | Phone: +1-(903)-675-9321, 800-927-4669
FDA Registration: 1625425
Products: Irrigation Sets & Tubing, General Medical Supplies, General Surgical Instruments, General Surgery Supplies, Syringe/Needle Combos, Guide Wire Accessories, ...
Argon Medical Devices Inc. manufactures and supplies single-use vascular access devices. Our products are divided into cardiology, radiology and critical care product lines. Our products include arter more...
Wexler Surgical | Address: 11333 Chimney Rock Road, Suite #120, Houston, Texas 77035, USA
www.wexlersurgical.com | Send Inquiry | Phone: +1-(713)-723-6900, 800-414-1076
FDA Registration: 1646747 Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: CE Certified
Products: Bone Rasps (FDA Code: HTR), Bone Clamp (FDA Code: HXD), Blood Collection Sets with Needle Holder, Blood Needle Holder Systems, Calipers (FDA Code: KTZ), Cannula Clamp (FDA Code: FKC), ...
Wexler Surgical offers the specialty surgical instrumentation in titanium and stainless steel for ophthalmic surgery. Our wide range of products include forceps, needle holders, scissors, retractors, more...
www.wexlersurgical.com | Send Inquiry | Phone: +1-(713)-723-6900, 800-414-1076
FDA Registration: 1646747 Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: CE Certified
Products: Bone Rasps (FDA Code: HTR), Bone Clamp (FDA Code: HXD), Blood Collection Sets with Needle Holder, Blood Needle Holder Systems, Calipers (FDA Code: KTZ), Cannula Clamp (FDA Code: FKC), ...
Wexler Surgical offers the specialty surgical instrumentation in titanium and stainless steel for ophthalmic surgery. Our wide range of products include forceps, needle holders, scissors, retractors, more...
Avid Medical, Inc. | Address: 9000 Westmont Dr., Stonehouse Commerce Park, Toano, Virginia 23168, USA
www.avidmedical.com | Send Inquiry | Phone: +1-(888)-564-7153
FDA Registration: 1047429
Products: Procedure Trays, Trays, Spinal Needles, Custom/Special Procedure Tray, Specialty Needles, Epidural Needles, ...
Avid Medical, Inc. deals with custom procedure trays. Our products include CPTs, Avid standards, anesthesia and procedure+plus. Our anesthesia products include specialty spinal and epidural needles & more...
www.avidmedical.com | Send Inquiry | Phone: +1-(888)-564-7153
FDA Registration: 1047429
Products: Procedure Trays, Trays, Spinal Needles, Custom/Special Procedure Tray, Specialty Needles, Epidural Needles, ...
Avid Medical, Inc. deals with custom procedure trays. Our products include CPTs, Avid standards, anesthesia and procedure+plus. Our anesthesia products include specialty spinal and epidural needles & more...
Hospital & Homecare Imp. & Exp. Co., Ltd. | Address: Room 608-611, No.5 Zhongtai Int. Plaza, No.311 Middle of Jiangdong Rd, Central Business Dist, Nanjing, Jiangsu, China 
www.aline-medical.com | Send Inquiry | Phone: +86-(25)-84573232
FDA Registration: 3006897996
Products: Adhesive Bandages (FDA Code: KGX), Adult Tongue Depressor (FDA Code: FMA), Cardiovascular Biopsy Needle (FDA Code: DWO), Adhesive Tape Solvent (FDA Code: KOX), Aerosol Adhesive Drape (FDA Code: KGT), Cast Bandage (FDA Code: ITG), ...
Hospital & Homecare Imp. & Exp. Co., Ltd. is mainly engaged in medical product development, covering thousands of products within the medical field. We provide Surgical & Optical Instruments, Laborato more...
www.aline-medical.com | Send Inquiry | Phone: +86-(25)-84573232
FDA Registration: 3006897996
Products: Adhesive Bandages (FDA Code: KGX), Adult Tongue Depressor (FDA Code: FMA), Cardiovascular Biopsy Needle (FDA Code: DWO), Adhesive Tape Solvent (FDA Code: KOX), Aerosol Adhesive Drape (FDA Code: KGT), Cast Bandage (FDA Code: ITG), ...
Hospital & Homecare Imp. & Exp. Co., Ltd. is mainly engaged in medical product development, covering thousands of products within the medical field. We provide Surgical & Optical Instruments, Laborato more...
Kayee M.O. House Co., Ltd. | Address: 8f, No. 59, Yeong Ho Road, Sec. 2, Yeong Ho, TW-TPQ 23444, Taiwan 
Products: Cardiovascular Biopsy Needle (FDA Code: DWO), ...
Kayee M.O. House Co., Ltd. specializes in offering personal and healthcare products. more...
Products: Cardiovascular Biopsy Needle (FDA Code: DWO), ...
Kayee M.O. House Co., Ltd. specializes in offering personal and healthcare products. more...
Combined Instruments (Pvt.), Ltd. | Address: 13-A Model Town, Ugoki, Sailkot, Pakistan
Phone: +92-(432)-510243
Products: Adenoid Punches (FDA Code: KBS), Adult Tongue Depressor (FDA Code: FMA), Adjustable Frequency Tuning Fork, A.V.Fistula Needle Set, A.V. Fistula Needle, Acoustical Fetal Holograph (FDA Code: HHX), ...
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: Adenoid Punches (FDA Code: KBS), Adult Tongue Depressor (FDA Code: FMA), Adjustable Frequency Tuning Fork, A.V.Fistula Needle Set, A.V. Fistula Needle, Acoustical Fetal Holograph (FDA Code: HHX), ...
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...
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: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Laser Power Probe, Laparoscopic Probes, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ...
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: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Laser Power Probe, Laparoscopic Probes, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ...
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...
Sterylab S.R.L. | Address: Via Magenta, 77/6, Rho, MI 20017, Italy
www.sterylab.it | Send Inquiry | Phone: +39-(02)-93 50 84 27
FDA Registration: 3007748770 Annual Revenues: USD 5-10 Million Employee Count: ~20 Quality: ISO 9001 and 13485, CE Certified
Products: Reusable Bone Marrow Needles, Bone Marrow Needle, Cardiovascular Biopsy Needle (FDA Code: DWO), Disposable Aspiration and Injection Needle (FDA Code: GAA), Disposable Surgical Instrument (FDA Code: KDC), Non-Metal Vaginal Speculum (FDA Code: HIB), ...
Sterylab S.R.L. is a provider of medical needles and devices. We offer products for antenatal diagnostic, clinical oncology, gynecology, infection control, interventional radiology, mammography, urolo more...
www.sterylab.it | Send Inquiry | Phone: +39-(02)-93 50 84 27
FDA Registration: 3007748770 Annual Revenues: USD 5-10 Million Employee Count: ~20 Quality: ISO 9001 and 13485, CE Certified
Products: Reusable Bone Marrow Needles, Bone Marrow Needle, Cardiovascular Biopsy Needle (FDA Code: DWO), Disposable Aspiration and Injection Needle (FDA Code: GAA), Disposable Surgical Instrument (FDA Code: KDC), Non-Metal Vaginal Speculum (FDA Code: HIB), ...
Sterylab S.R.L. is a provider of medical needles and devices. We offer products for antenatal diagnostic, clinical oncology, gynecology, infection control, interventional radiology, mammography, urolo more...
Lifeline Systems Pvt Ltd | Address: F-40, 1st Floor Okhla Industrial Area, Phase - 1, New Delhi, Delhi 110 020, India 
www.lifelinedelhi.com | Send Inquiry | Phone: +91-(11)-416-40924
Quality: ISO 9001:2000, ISO 14001:2004, ISO 13485:2003 Certified
Products: Catheter Accessories (FDA Code: KGZ), Cardiovascular Surgical Instrument (FDA Code: DWS), Anesthesiology Oropharyngeal Airway (FDA Code: CAE), Cardiopulmonary Bypass Accessories (FDA Code: KRI), Cardiovascular Biopsy Needle (FDA Code: DWO), Catheter Needle (FDA Code: GCB), ...
Lifeline Systems Pvt. Ltd. is engaged in the production of medical and surgical disposables. We provide products for fields such as anesthesia, gynecology, urology and cardiology. Our hemodialysis blo more...
www.lifelinedelhi.com | Send Inquiry | Phone: +91-(11)-416-40924
Quality: ISO 9001:2000, ISO 14001:2004, ISO 13485:2003 Certified
Products: Catheter Accessories (FDA Code: KGZ), Cardiovascular Surgical Instrument (FDA Code: DWS), Anesthesiology Oropharyngeal Airway (FDA Code: CAE), Cardiopulmonary Bypass Accessories (FDA Code: KRI), Cardiovascular Biopsy Needle (FDA Code: DWO), Catheter Needle (FDA Code: GCB), ...
Lifeline Systems Pvt. Ltd. is engaged in the production of medical and surgical disposables. We provide products for fields such as anesthesia, gynecology, urology and cardiology. Our hemodialysis blo 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: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Y-Stent Forceps, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ENT Forceps (FDA Code: KAE), ...
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: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Y-Stent Forceps, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ENT Forceps (FDA Code: KAE), ...
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...
Elcon Medical Instruments GmbH | Address: Dr. Karl-Storz-Straße 26, Tuttlingen D-78532, Germany 
www.elcon-medical.com | Send Inquiry | Phone: +49-(7461)-9281-0
FDA Registration: 8043816 Quality: ISO 13485:2003 Certified
Products: Adenotomes (FDA Code: KBH), General & Plastic Surgery Surgical Cannula (FDA Code: GEA), Ruler and Caliper (FDA Code: FTY), Ophthalmic Suturring Needle (FDA Code: HNM), Tonsil Suturing Needle (FDA Code: KBR), Inflation Bulb For Endoscope (FDA Code: FCY), ...
Elcon Medical Instruments GmbH is a manufacturer and distributor of surgical instruments. Our wide range of instruments cover all surgical disciplines. We offer instruments for general surgery, gyneco more...
www.elcon-medical.com | Send Inquiry | Phone: +49-(7461)-9281-0
FDA Registration: 8043816 Quality: ISO 13485:2003 Certified
Products: Adenotomes (FDA Code: KBH), General & Plastic Surgery Surgical Cannula (FDA Code: GEA), Ruler and Caliper (FDA Code: FTY), Ophthalmic Suturring Needle (FDA Code: HNM), Tonsil Suturing Needle (FDA Code: KBR), Inflation Bulb For Endoscope (FDA Code: FCY), ...
Elcon Medical Instruments GmbH is a manufacturer and distributor of surgical instruments. Our wide range of instruments cover all surgical disciplines. We offer instruments for general surgery, gyneco 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...
Vehu Medical Gmbh | Address: 48 Semmelweisstraße, Tuttlingen 78532, Germany
www.vehu.com | Send Inquiry | Phone: +49-(7461)-163311
FDA Registration: 9616246
Products: Balloon Urethral Dilator Sets, Balloon Urethral Dilator Catheters, Angular Ear Curette, Adjustable Frequency Tuning Fork, Aluminium Tuning Fork, AC-Powered Operating Headlamp (FDA Code: HPQ), ...
Vehu Medical Gmbh provides surgical accessory applicator, cotton, forceps, extractor, scissors, ophthalmic fork, syringe, retractor, stethoscopes, head mirrors, needles, dissector, surgical clip, oper more...
www.vehu.com | Send Inquiry | Phone: +49-(7461)-163311
FDA Registration: 9616246
Products: Balloon Urethral Dilator Sets, Balloon Urethral Dilator Catheters, Angular Ear Curette, Adjustable Frequency Tuning Fork, Aluminium Tuning Fork, AC-Powered Operating Headlamp (FDA Code: HPQ), ...
Vehu Medical Gmbh provides surgical accessory applicator, cotton, forceps, extractor, scissors, ophthalmic fork, syringe, retractor, stethoscopes, head mirrors, needles, dissector, surgical clip, oper more...
M.S. Medi Syst | Address: Gewerbering 22, Rheinstetten, Baden 76287, Germany
www.medisyst.de | Send Inquiry | Phone: +49-(7242)-938830
Annual Revenues: USD 1-5 Million Quality: ISO 9002, CE Certified
Products: Bulb Syringes, Disposable Irrigation Bulb Syringe, Polyethylene Tubing Adapter, Epidural Catheter Kit, Polyethylene Tubing, Bulb Irrigation Syringe, ...
M.S. Medi Syst produces, sterilizes and packages disposable medical products & components. Our products include urological catheters & drainage systems, central venous catheters, introducer sets, radi more...
www.medisyst.de | Send Inquiry | Phone: +49-(7242)-938830
Annual Revenues: USD 1-5 Million Quality: ISO 9002, CE Certified
Products: Bulb Syringes, Disposable Irrigation Bulb Syringe, Polyethylene Tubing Adapter, Epidural Catheter Kit, Polyethylene Tubing, Bulb Irrigation Syringe, ...
M.S. Medi Syst produces, sterilizes and packages disposable medical products & components. Our products include urological catheters & drainage systems, central venous catheters, introducer sets, radi more...
Daum Gmbh | Address: Hagenower Str. 73, Schwerin, Meckl 19061, Germany
www.daum.de | Send Inquiry | Phone: +49-(385)-3993 109
Annual Revenues: < USD 1 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Vertebral Body Biopsy Kit, Liver Biopsy kit, Endometrial Biopsy Kit, Acupuncture Needles, Biopsy Kit, Puncture Needle, ...
Daum Gmbh specializes in interventional procedures under magnetic resonance imaging guidance. Our TrackPointer™ is a minimally invasive instrument. It allows best orientation and facilitates the more...
www.daum.de | Send Inquiry | Phone: +49-(385)-3993 109
Annual Revenues: < USD 1 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Vertebral Body Biopsy Kit, Liver Biopsy kit, Endometrial Biopsy Kit, Acupuncture Needles, Biopsy Kit, Puncture Needle, ...
Daum Gmbh specializes in interventional procedures under magnetic resonance imaging guidance. Our TrackPointer™ is a minimally invasive instrument. It allows best orientation and facilitates the more...
Laurane Medical S.A.R.L. | Address: 100, Rue Du Docteur Roux, La Farlede 83210, France
Phone: +33-(860)-3999900
FDA Registration: 3006554818
Products: Drill Bit (FDA Code: HTW), Bone Biopsy Products, Cardiovascular Biopsy Needle (FDA Code: DWO), Disposable Aspiration and Injection Needle (FDA Code: GAA), General & Plastic Surgery Surgical Cannula (FDA Code: GEA), ...
Laurane Medical S.A.R.L. offers a range of bone biopsy kits. more...
Phone: +33-(860)-3999900
FDA Registration: 3006554818
Products: Drill Bit (FDA Code: HTW), Bone Biopsy Products, Cardiovascular Biopsy Needle (FDA Code: DWO), Disposable Aspiration and Injection Needle (FDA Code: GAA), General & Plastic Surgery Surgical Cannula (FDA Code: GEA), ...
Laurane Medical S.A.R.L. offers a range of bone biopsy kits. more...
Suturex & Renodex S.A. | Address: Zone De Vialard Carsac, Sarlat La Caneda 24200, France
www.suturex-renodex.com | Send Inquiry | Phone: +33-(5)-53313453
FDA Registration: 3003192334
Products: Surgical Needles, Reusable, Surgical Sutural Needles, Reverse Cutting Needles, Circle Taper Point Suture Needle, Cutting Shaped Suture Needles, Disposable Suture Needle (FDA Code: GAB), ...
Suturex & Renodex S.A. manufactures surgical needles. Our surgical needles include cutting needles, taper point, taper cutting, micro needle and specialty needles. We provide cutting needles that are more...
www.suturex-renodex.com | Send Inquiry | Phone: +33-(5)-53313453
FDA Registration: 3003192334
Products: Surgical Needles, Reusable, Surgical Sutural Needles, Reverse Cutting Needles, Circle Taper Point Suture Needle, Cutting Shaped Suture Needles, Disposable Suture Needle (FDA Code: GAB), ...
Suturex & Renodex S.A. manufactures surgical needles. Our surgical needles include cutting needles, taper point, taper cutting, micro needle and specialty needles. We provide cutting needles that are 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...
William Cook Europe Aps | Address: Sandet 6, Dk-4632, Bjaeverskov, Denmark
www.cookmedical.com/profile.do?id=profile_europe | Send Inquiry | Phone: +45-(568)-68593
FDA Registration: 3002808486 Year Established: 1969
Products: Cardiovascular Biopsy Needle (FDA Code: DWO), Guidewire Catheter (FDA Code: DQX), Endovascular Grafts for Treatment of Abdominal Aortic Aneurysm (FDA Code: MIH), General & Plastic Surgery Nephrostomy Catheter (FDA Code: GBO), Tumor Localization Needle (FDA Code: MIJ), ENT Manual Surgical Instrument (FDA Code: LRC), ...
William Cook Europe Aps specializes in products for endovascular therapy, critical care medicine, general surgery, diagnostic & interventional procedures, bioengineered tissue replacement & regenerati more...
www.cookmedical.com/profile.do?id=profile_europe | Send Inquiry | Phone: +45-(568)-68593
FDA Registration: 3002808486 Year Established: 1969
Products: Cardiovascular Biopsy Needle (FDA Code: DWO), Guidewire Catheter (FDA Code: DQX), Endovascular Grafts for Treatment of Abdominal Aortic Aneurysm (FDA Code: MIH), General & Plastic Surgery Nephrostomy Catheter (FDA Code: GBO), Tumor Localization Needle (FDA Code: MIJ), ENT Manual Surgical Instrument (FDA Code: LRC), ...
William Cook Europe Aps specializes in products for endovascular therapy, critical care medicine, general surgery, diagnostic & interventional procedures, bioengineered tissue replacement & regenerati more...
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FDA Code / Regulation: DWO / 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.
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