Rectal Speculums Suppliers
Limit companies to: Worldwide USA
Sontec Instruments, Inc. | Address: 7248 South Tucson Way, Colorado 80112, USA 
www.sontecinstruments.com | Send Inquiry | Phone: +1-(303)-790-9411
FDA Registration: 1720747 Employee Count: ~20
Products: Curettes, Manipulators, Rotators, Spatulas and Picks, Lacrimal Dilators and Cannulas, Fixation Rings, Vannas Capsulotomy Scissors, Intraocular Lens Manipulators, ...
Sontec Instruments, Inc. supplies surgical instrumentation to the medical industry. We deliver a complete line of surgical instruments for cardiovascular/thoracic, urological, gynecological/obstetrica more...
www.sontecinstruments.com | Send Inquiry | Phone: +1-(303)-790-9411
FDA Registration: 1720747 Employee Count: ~20
Products: Curettes, Manipulators, Rotators, Spatulas and Picks, Lacrimal Dilators and Cannulas, Fixation Rings, Vannas Capsulotomy Scissors, Intraocular Lens Manipulators, ...
Sontec Instruments, Inc. supplies surgical instrumentation to the medical industry. We deliver a complete line of surgical instruments for cardiovascular/thoracic, urological, gynecological/obstetrica more...
KLS Martin, L.P. | Address: 11239-1 St.Johns Industrial Parkway S, Jacksonville, Florida 32246-7652, USA
www.klsmartinusa.com | Send Inquiry | Phone: +1-(904)-641-7746, 800-625-1557
FDA Registration: 1057946 Year Established: 1993 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9001 Certified
Products: Elevators, Instruments, Castroviejo Calipers, Neurological Instruments, Pituitary Scoops, Cervical Spine Retractor System, Hand Held Instruments, Periosteals Elevators, ...
KLS Martin, L.P. focuses on surgical fields. Our mario® instrument management software manages & controls sterile supplies according to economic, technical & process-oriented criteria. Our C-plate more...
www.klsmartinusa.com | Send Inquiry | Phone: +1-(904)-641-7746, 800-625-1557
FDA Registration: 1057946 Year Established: 1993 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9001 Certified
Products: Elevators, Instruments, Castroviejo Calipers, Neurological Instruments, Pituitary Scoops, Cervical Spine Retractor System, Hand Held Instruments, Periosteals Elevators, ...
KLS Martin, L.P. focuses on surgical fields. Our mario® instrument management software manages & controls sterile supplies according to economic, technical & process-oriented criteria. Our C-plate more...
Marina Medical Instruments Inc. | Address: 955 Shotgun Rd, Sunrise, Florida 33326, USA
www.marinamedical.com | Send Inquiry | Phone: +1-(954)-924-4418, 800-697-1119
FDA Registration: 2084346 Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO Certified
Products: Curettes, Hemostatic Mosquito Forceps, Adson Tissue Forceps, Jewelers Bipolar Forceps, Jaeger Lid Plates, Bone Curettes, ...
Marina Medical Instruments Inc. supplies medical instruments. Our product range comprises of vaginal agenesis, fan retractors, pelvic surgery, surgical caps, scopes, electrosurgical, cystoscopy & bari more...
www.marinamedical.com | Send Inquiry | Phone: +1-(954)-924-4418, 800-697-1119
FDA Registration: 2084346 Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO Certified
Products: Curettes, Hemostatic Mosquito Forceps, Adson Tissue Forceps, Jewelers Bipolar Forceps, Jaeger Lid Plates, Bone Curettes, ...
Marina Medical Instruments Inc. supplies medical instruments. Our product range comprises of vaginal agenesis, fan retractors, pelvic surgery, surgical caps, scopes, electrosurgical, cystoscopy & bari more...
Elmed Inc. | Address: 60 West fay avenue, Addison, Illinois 60101, USA
www.elmed.com | Send Inquiry | Phone: +1-(630)-543-2792
FDA Registration: 1412854 Annual Revenues: USD 1-5 Million Employee Count: ~20
Products: Monopolar Aids, Foot Switching, Handswitching, Monopolar Generators, Generators, Anterior Cruciate Ligament Surgical Reconstruction System, ...
Elmed Inc. specializes in reusable electrosurgical equipment & accessories. We are involved in monopolar electrosurgical technology. Our retract robot is designed to assist surgeons during intensive p more...
www.elmed.com | Send Inquiry | Phone: +1-(630)-543-2792
FDA Registration: 1412854 Annual Revenues: USD 1-5 Million Employee Count: ~20
Products: Monopolar Aids, Foot Switching, Handswitching, Monopolar Generators, Generators, Anterior Cruciate Ligament Surgical Reconstruction System, ...
Elmed Inc. specializes in reusable electrosurgical equipment & accessories. We are involved in monopolar electrosurgical technology. Our retract robot is designed to assist surgeons during intensive p more...
Vyaire Medical, Inc. | Address: 26125 North Riverwoods Blvd, Mettawa, Illinois 60045, USA
www.vyaire.com | Send Inquiry | Phone: +1-(610)-862-0800
FDA Registration: 2050001 Year Established: 2001 Annual Revenues: USD 50-100 Million Employee Count: ~230 Quality: ISO 9001, CE Certified
Products: Speech & Testing Equipment, Impedance Testing Systems, Audiometers & Accessories, Evoked Response Testing Systems, Infant Screening & Testing Units, Otoacoustic Emission Test Equipment, ...
Vyaire Medical, Inc. develops & distributes technology medical devices that are used in respiratory care, neurology, vascular medicine and critical care. Our Infant Flow® SiPAP™ renders bi-l more...
www.vyaire.com | Send Inquiry | Phone: +1-(610)-862-0800
FDA Registration: 2050001 Year Established: 2001 Annual Revenues: USD 50-100 Million Employee Count: ~230 Quality: ISO 9001, CE Certified
Products: Speech & Testing Equipment, Impedance Testing Systems, Audiometers & Accessories, Evoked Response Testing Systems, Infant Screening & Testing Units, Otoacoustic Emission Test Equipment, ...
Vyaire Medical, Inc. develops & distributes technology medical devices that are used in respiratory care, neurology, vascular medicine and critical care. Our Infant Flow® SiPAP™ renders bi-l more...
Luxtec | Address: 99 Hartwell Street, West Boylston, Maryland 01583, USA
www.luxtec.com | Send Inquiry | Phone: +1-(508)-835-9700
Year Established: 1981 Annual Revenues: USD 10-25 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Light Sources, Surgical Headlights, Recording Systems, Headlight Box / Light source, Digital Video Recorders, Recording Devices, ...
Luxtec produces medical illumination systems. We develop lighting and visualization systems for the operating room. Our products include headlights, ultralite, halogen, camera, surgical loupes, monito more...
www.luxtec.com | Send Inquiry | Phone: +1-(508)-835-9700
Year Established: 1981 Annual Revenues: USD 10-25 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Light Sources, Surgical Headlights, Recording Systems, Headlight Box / Light source, Digital Video Recorders, Recording Devices, ...
Luxtec produces medical illumination systems. We develop lighting and visualization systems for the operating room. Our products include headlights, ultralite, halogen, camera, surgical loupes, monito more...
Codman & Shurtleff, Inc. | Address: 325 Paramount Dr., Raynham, Massachusetts 02767, USA
www.codman.com | Send Inquiry | Phone: +1-(508)-880-8100
FDA Registration: 1226348 Year Established: 1857 Annual Revenues: < USD 1 Million Employee Count: ~1200 Quality: ISO 9000 Certified
Products: Anterior Cervical Fusion Kit, Cervical Drill Tips, Cervical Drill Guards, Cross Bar Handle, Depth Gauge (FDA Code: HTJ), Spanner Gauge, ...
Codman & Shurtleff, Inc. develops and markets a wide range of diagnostic & therapeutic products for the treatment of central nervous system disorders. Our focus is on intractable pain management, pedi more...
www.codman.com | Send Inquiry | Phone: +1-(508)-880-8100
FDA Registration: 1226348 Year Established: 1857 Annual Revenues: < USD 1 Million Employee Count: ~1200 Quality: ISO 9000 Certified
Products: Anterior Cervical Fusion Kit, Cervical Drill Tips, Cervical Drill Guards, Cross Bar Handle, Depth Gauge (FDA Code: HTJ), Spanner Gauge, ...
Codman & Shurtleff, Inc. develops and markets a wide range of diagnostic & therapeutic products for the treatment of central nervous system disorders. Our focus is on intractable pain management, pedi more...
Kmedic | Address: 190 Veterans Drive, Northvale, New Jersey 07647, USA
www.kmedic.com | Send Inquiry | Phone: +1-(201)-767-4002
FDA Registration: 3012164475 Year Established: 1986 Annual Revenues: < USD 1 Million Quality: ISO Certified
Products: Curettes, Forceps (FDA Code: HTD), Mallets, Retractors, Scissors, Bone Cutters, ...
Kmedic produces & supply instruments for sutures, ligation, chest drains, surgical, wound closure systems, cardiac surgery and anesthesiology. We are an ISO 9001 certified company. We offer products l more...
www.kmedic.com | Send Inquiry | Phone: +1-(201)-767-4002
FDA Registration: 3012164475 Year Established: 1986 Annual Revenues: < USD 1 Million Quality: ISO Certified
Products: Curettes, Forceps (FDA Code: HTD), Mallets, Retractors, Scissors, Bone Cutters, ...
Kmedic produces & supply instruments for sutures, ligation, chest drains, surgical, wound closure systems, cardiac surgery and anesthesiology. We are an ISO 9001 certified company. We offer products l more...
Ellman International, Inc. | Address: 3333 Royal Ave, Oceanside, New York 11572, USA
www.ellman.com | Send Inquiry | Phone: +1-(516)-594-3333, 800-835-5355
FDA Registration: 2428235 Annual Revenues: USD 5-10 Million Employee Count: ~80 Quality: ISO 9001, CE Certified
Products: Standard, Anesthesia, Blood Collection Needles, EKG Supplies, Electrosurgery, Eyeshields, ...
Ellman International, Inc. designs & manufactures radiosurgical device, electrodes, smoke evacuation unit, gynecology, dermatology, plastic surgery, and podiatry. The radiosirgical device includes neu more...
www.ellman.com | Send Inquiry | Phone: +1-(516)-594-3333, 800-835-5355
FDA Registration: 2428235 Annual Revenues: USD 5-10 Million Employee Count: ~80 Quality: ISO 9001, CE Certified
Products: Standard, Anesthesia, Blood Collection Needles, EKG Supplies, Electrosurgery, Eyeshields, ...
Ellman International, Inc. designs & manufactures radiosurgical device, electrodes, smoke evacuation unit, gynecology, dermatology, plastic surgery, and podiatry. The radiosirgical device includes neu more...
Welch Allyn, Inc. | Address: 4341 State Street Road, Skaneateles Falls, New York 13153-0220, USA
www.welchallyn.com | Send Inquiry | Phone: +001-(800)-535-6663
FDA Registration: 1316463 Year Established: 1915 Annual Revenues: USD 100-500 Million Employee Count: ~2700 Quality: ISO 9001, CE Certified
Products: EKG Supplies, Adjustable Sphygmomanometer, 2.5v Vacuum Lamp, Accessories For Headlight System, AA Battery, AAA Battery, ...
Welch Allyn, Inc. is a medical device company. We manufacture innovative medical diagnostic equipment & therapeutic devices, cardiac defibrillators, patient monitoring systems and miniature precision more...
www.welchallyn.com | Send Inquiry | Phone: +001-(800)-535-6663
FDA Registration: 1316463 Year Established: 1915 Annual Revenues: USD 100-500 Million Employee Count: ~2700 Quality: ISO 9001, CE Certified
Products: EKG Supplies, Adjustable Sphygmomanometer, 2.5v Vacuum Lamp, Accessories For Headlight System, AA Battery, AAA Battery, ...
Welch Allyn, Inc. is a medical device company. We manufacture innovative medical diagnostic equipment & therapeutic devices, cardiac defibrillators, patient monitoring systems and miniature precision more...
Teleflex Medical | Address: PO Box 12600, Research Triangle Park, North Carolina 27709, USA
www.teleflexmedical.com | Send Inquiry | Phone: +1-(919)-544-8000
FDA Registration: 1044475 Annual Revenues: USD 50-100 Million Employee Count: ~380 Quality: ISO 9001, CE Certified
Products: Absorbable Sutures (FDA Code: GAK), General Diagnostic Supplies, General Medical Supplies, General Sutures/Needles, Non-Absorbable Sutures (FDA Code: GAO), Suture Needles, ...
Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical more...
www.teleflexmedical.com | Send Inquiry | Phone: +1-(919)-544-8000
FDA Registration: 1044475 Annual Revenues: USD 50-100 Million Employee Count: ~380 Quality: ISO 9001, CE Certified
Products: Absorbable Sutures (FDA Code: GAK), General Diagnostic Supplies, General Medical Supplies, General Sutures/Needles, Non-Absorbable Sutures (FDA Code: GAO), Suture Needles, ...
Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical more...
Aesculap Inc. | Address: 3773 Corporate Parkway, Center Valley, Pennsylvania 18034, USA
www.aesculapusa.com | Send Inquiry | Phone: +1-(800)-258-1946
FDA Registration: 2916714 Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~120
Products: Curettes, Drills, Titanium Plating Systems, Suction Tubes, Dural Substitute, Posterior, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou more...
www.aesculapusa.com | Send Inquiry | Phone: +1-(800)-258-1946
FDA Registration: 2916714 Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~120
Products: Curettes, Drills, Titanium Plating Systems, Suction Tubes, Dural Substitute, Posterior, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou more...
Sklar Instruments | Address: 889 S. Matlack St, West Chester, Pennsylvania 19382, USA
www.sklarcorp.com | Send Inquiry | Phone: +1-(610)-430-3200, 800-221-2166
FDA Registration: 2431166
Products: Alligator Forceps, Adult Stethoscope, Aneroid Sphygmomanometer, Aortic Aneurysm Clamps, Anastomosis Clamps, Adult Laryngoscope Lamp, ...
Sklar Instruments supplies surgical instruments. Our product categories are arthroscopy, dental, dermal, diagnostic, electrosurgery, genitourinary, and orthodontics. Our Sklar Tite™ line of seal more...
www.sklarcorp.com | Send Inquiry | Phone: +1-(610)-430-3200, 800-221-2166
FDA Registration: 2431166
Products: Alligator Forceps, Adult Stethoscope, Aneroid Sphygmomanometer, Aortic Aneurysm Clamps, Anastomosis Clamps, Adult Laryngoscope Lamp, ...
Sklar Instruments supplies surgical instruments. Our product categories are arthroscopy, dental, dermal, diagnostic, electrosurgery, genitourinary, and orthodontics. Our Sklar Tite™ line of seal more...
Miltex, Inc. | Address: 589 Davies Drive, York, Pennsylvania 17402, USA
www.miltex.com | Send Inquiry | Phone: +1-(717)-840-9335
FDA Registration: 2523190 Year Established: 1950 Employee Count: ~200 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Scissors, Vasectomy Ringed Forceps, Vasectomy Hemostats, General Medical Supplies, General Surgical Instruments, ...
Miltex, Inc. specializes in surgical and dental instruments. Our product line includes surgical, dental, gynecology, animal health, podiatry and repair instruments. Our Miltex® endometrial samplin more...
www.miltex.com | Send Inquiry | Phone: +1-(717)-840-9335
FDA Registration: 2523190 Year Established: 1950 Employee Count: ~200 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Scissors, Vasectomy Ringed Forceps, Vasectomy Hemostats, General Medical Supplies, General Surgical Instruments, ...
Miltex, Inc. specializes in surgical and dental instruments. Our product line includes surgical, dental, gynecology, animal health, podiatry and repair instruments. Our Miltex® endometrial samplin more...
Quality Medical Supply, Inc. | Address: 3334 W. Flower St, Phoenix, Arizona 85017, USA
www.qualitymedicalproductsupplies.com | Phone: +1-(877)-759-1277
FDA Registration: 3008274651
Products: Female Intermittent Catheters, Female Catheters, Cotton Tipped Applicators, Rectal Speculums (FDA Code: FFQ), Abdominal Pads, Medical Cotton Applicators, ...
Quality Medical Supply, Inc. specializes in medical supplies. We are an ISO 13485:2008 and ISO 9001:2000 certified company. Our product line includes catheters, blood pressure monitors, medical gloves more...
www.qualitymedicalproductsupplies.com | Phone: +1-(877)-759-1277
FDA Registration: 3008274651
Products: Female Intermittent Catheters, Female Catheters, Cotton Tipped Applicators, Rectal Speculums (FDA Code: FFQ), Abdominal Pads, Medical Cotton Applicators, ...
Quality Medical Supply, Inc. specializes in medical supplies. We are an ISO 13485:2008 and ISO 9001:2000 certified company. Our product line includes catheters, blood pressure monitors, medical gloves more...
Clearwater Colon Hydrotherapy, Inc. | Address: 3145 S.W. 74th Terrace, Ocala, Florida 34474, USA
www.colonhydrotherapy.com | Send Inquiry | Phone: +1-(352)-401-0303, 888-869-6191
FDA Registration: 1062839 Year Established: 1992 Annual Revenues: < USD 1 Million Quality: ISO Certified
Products: Folding Massage Table, Rectal Speculums (FDA Code: FFQ), Colonic Irrigation System (FDA Code: KPL), Therapist Work Chairs, Hydrotherapy Systems, Ultra Violet Water Filters, ...
Clearwater Colon Hydrotherapy, Inc. supplies colon hydrotherapy equipment. Our PPC-101 Colon Hydrotherapy System is portable (on caster wheels) with quick disconnects for water, sewer and electrical l more...
www.colonhydrotherapy.com | Send Inquiry | Phone: +1-(352)-401-0303, 888-869-6191
FDA Registration: 1062839 Year Established: 1992 Annual Revenues: < USD 1 Million Quality: ISO Certified
Products: Folding Massage Table, Rectal Speculums (FDA Code: FFQ), Colonic Irrigation System (FDA Code: KPL), Therapist Work Chairs, Hydrotherapy Systems, Ultra Violet Water Filters, ...
Clearwater Colon Hydrotherapy, Inc. supplies colon hydrotherapy equipment. Our PPC-101 Colon Hydrotherapy System is portable (on caster wheels) with quick disconnects for water, sewer and electrical l more...
Bio-Bridge Science, Inc. | Address: 1211 West 22nd St., Suite 615, Oak Brook, Illinois 60523, USA
www.bbsinstruments.com | Send Inquiry | Phone: +1-(630)-9280869
Products: Saws (FDA Code: HSO), General & Plastic Saw Surgical Blade (FDA Code: GFA), Drill Handpiece (Brace) (FDA Code: HBD), Surgical Knife (FDA Code: EMF), Neurosurgical Suture Needle (FDA Code: HAS), Gynecological Cerclage Needle (FDA Code: HDH), ...
Bio-Bridge Science, Inc. is a provider of surgical and dental instruments. Our surgical instruments include surgical clamps, forceps, scalpel handles, scissors, tweezers and retractors. Our dental ins more...
www.bbsinstruments.com | Send Inquiry | Phone: +1-(630)-9280869
Products: Saws (FDA Code: HSO), General & Plastic Saw Surgical Blade (FDA Code: GFA), Drill Handpiece (Brace) (FDA Code: HBD), Surgical Knife (FDA Code: EMF), Neurosurgical Suture Needle (FDA Code: HAS), Gynecological Cerclage Needle (FDA Code: HDH), ...
Bio-Bridge Science, Inc. is a provider of surgical and dental instruments. Our surgical instruments include surgical clamps, forceps, scalpel handles, scissors, tweezers and retractors. Our dental ins more...
Monarch Molding, Inc. | Address: P.O. Box 279, Council Grove, Kansas 66846, USA
www.monarchmoldinginc.com | Send Inquiry | Phone: +1-(620)-767-5115, 888-767-5116
FDA Registration: 1925197 Year Established: 1968 Annual Revenues: < USD 1 Million Employee Count: ~10
Products: General Medical Supplies, Proctology Kit, Vaginal & Cervical Specula, Disposable Vaginal Speculum, Facial Proctology Kit, Medical Instruments, Proctology Kit, ...
Monarch Molding, Inc. is an injection molding company that manufactures medical and telecommunications line of products. We are a registered FDA manufacturer of medical devices. We manufacture disposa more...
www.monarchmoldinginc.com | Send Inquiry | Phone: +1-(620)-767-5115, 888-767-5116
FDA Registration: 1925197 Year Established: 1968 Annual Revenues: < USD 1 Million Employee Count: ~10
Products: General Medical Supplies, Proctology Kit, Vaginal & Cervical Specula, Disposable Vaginal Speculum, Facial Proctology Kit, Medical Instruments, Proctology Kit, ...
Monarch Molding, Inc. is an injection molding company that manufactures medical and telecommunications line of products. We are a registered FDA manufacturer of medical devices. We manufacture disposa more...
Symmetry Medical Inc. | Address: New Bedford Industrial Park, New Bedford, Massachusetts 02745, USA
www.symmetrymedical.com | Phone: +1-(508)-998-4493
Products: Calipers, Flexible Osteotome System, Bone Tamp, Orthopedic Caliper, Reamer (FDA Code: HTO), Screw Removal Systems, ...
Symmetry Medical Inc. manufactures implants, instruments and cases to orthopedic devices. We offer cases and trays that made of metal, plastic or hybrid. We provide forged, cast, machined and finished more...
www.symmetrymedical.com | Phone: +1-(508)-998-4493
Products: Calipers, Flexible Osteotome System, Bone Tamp, Orthopedic Caliper, Reamer (FDA Code: HTO), Screw Removal Systems, ...
Symmetry Medical Inc. manufactures implants, instruments and cases to orthopedic devices. We offer cases and trays that made of metal, plastic or hybrid. We provide forged, cast, machined and finished more...
Electro Surgical Instrument Co., Inc. | Address: 37 Centennial St., Rochester, New York 14611, USA
www.electrosurgicalinstrument.com | Send Inquiry | Phone: +1-(585)-235-1430, 888-464-2784
FDA Registration: 1315756 Year Established: 1896 Annual Revenues: < USD 1 Million Quality: ISO Certified
Products: Airways & Bite Blocks, Oral Airways, Airways & Bite Blocks, Bite Guards and Blocks, Airways & Bite Blocks, Fiberoptic Intubating Airway, Adult Tongue Depressor (FDA Code: FMA), Adult Universal Bite Block, AC-Powered Transilluminator (FDA Code: HJM), ...
Electro Surgical Instrument Co., Inc.is a manufacturer of lighted medical instruments. Our products include lighting system components, neurosurgical instruments, nasal instruments, transilluminators, more...
www.electrosurgicalinstrument.com | Send Inquiry | Phone: +1-(585)-235-1430, 888-464-2784
FDA Registration: 1315756 Year Established: 1896 Annual Revenues: < USD 1 Million Quality: ISO Certified
Products: Airways & Bite Blocks, Oral Airways, Airways & Bite Blocks, Bite Guards and Blocks, Airways & Bite Blocks, Fiberoptic Intubating Airway, Adult Tongue Depressor (FDA Code: FMA), Adult Universal Bite Block, AC-Powered Transilluminator (FDA Code: HJM), ...
Electro Surgical Instrument Co., Inc.is a manufacturer of lighted medical instruments. Our products include lighting system components, neurosurgical instruments, nasal instruments, transilluminators, more...
Sponsored Links
FDA Code / Regulation: FFQ / 876.4730
A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop.
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 876.9.
