Manual Gastro-Urology Surgical Instrument Suppliers
Limit companies to: Worldwide USA
Laserscope | Address: 3070 Orchard Drive, San Jose, California 95134-2011, USA 
www.laserscope.com | Send Inquiry | Phone: +1-(408)-943-0636, (800)-356-7600
FDA Registration: 2937094 Year Established: 1984 Annual Revenues: USD 100-500 Million Employee Count: ~120 Quality: ISO 9001, CE Certified
Products: Dermatological Equipment, Cosmetic Lasers, Powered Surgical Laser Instrument (FDA Code: GEX), Cosmetic Lasers, Contact/non contact mode, Hair Removal Device, Hair Removal Kits, ...
Laserscope focuses on pelvic health. We offer solutions for men and women in the areas of urinary incontinence, fecal incontinence, vaginal prolapse treatment, uterine health, erectile restoration, an more...
www.laserscope.com | Send Inquiry | Phone: +1-(408)-943-0636, (800)-356-7600
FDA Registration: 2937094 Year Established: 1984 Annual Revenues: USD 100-500 Million Employee Count: ~120 Quality: ISO 9001, CE Certified
Products: Dermatological Equipment, Cosmetic Lasers, Powered Surgical Laser Instrument (FDA Code: GEX), Cosmetic Lasers, Contact/non contact mode, Hair Removal Device, Hair Removal Kits, ...
Laserscope focuses on pelvic health. We offer solutions for men and women in the areas of urinary incontinence, fecal incontinence, vaginal prolapse treatment, uterine health, erectile restoration, an more...
Advanced Bionics Corporation | Address: 12740 San Fernando Road, Sylmar, California 91342, USA
www.advancedbionics.com | Send Inquiry | Phone: +1-(661)-362-1400
FDA Registration: 3006556115
Products: Magnetic Stimulators, Commercial Magnetic Stimulators, Bio-Magnetic Stimulators, Non-Invasive Magnetic Stimulators, Water Vooled Magnetic Stimulators, Hearing Aid Batteries and Accessories, ...
Advanced Bionics Corporation focuses on the development of implantable, high-technology neuro stimulation devices. We concentrate in the manufacture of cochlear implant technology (restores hearing to more...
www.advancedbionics.com | Send Inquiry | Phone: +1-(661)-362-1400
FDA Registration: 3006556115
Products: Magnetic Stimulators, Commercial Magnetic Stimulators, Bio-Magnetic Stimulators, Non-Invasive Magnetic Stimulators, Water Vooled Magnetic Stimulators, Hearing Aid Batteries and Accessories, ...
Advanced Bionics Corporation focuses on the development of implantable, high-technology neuro stimulation devices. We concentrate in the manufacture of cochlear implant technology (restores hearing to more...
Autosuture | Address: 150 Glover Avenue, Norwalk, Connecticut 06856, USA
www.autosuture.com | Send Inquiry | Phone: +1-(800)-722-8772
Annual Revenues: > USD 1 Billion Employee Count: ~5780 Quality: ISO 9001, ISO 9002, CE Certified
Products: Forceps (FDA Code: HTD), Retractors, Scissors, Meniscal Repair Systems, Absorbable Suture Anchors, Suture Anchors, ...
Autosuture offers a complete line of surgical products and instrumentation that surgeons utilize for laparoscopic, endoscopic & traditional open surgical procedures & lymphatic mapping. We are an ISO more...
www.autosuture.com | Send Inquiry | Phone: +1-(800)-722-8772
Annual Revenues: > USD 1 Billion Employee Count: ~5780 Quality: ISO 9001, ISO 9002, CE Certified
Products: Forceps (FDA Code: HTD), Retractors, Scissors, Meniscal Repair Systems, Absorbable Suture Anchors, Suture Anchors, ...
Autosuture offers a complete line of surgical products and instrumentation that surgeons utilize for laparoscopic, endoscopic & traditional open surgical procedures & lymphatic mapping. We are an ISO more...
Cooper Surgical, Inc. | Address: 95 Corporate Drive, Trumbul, Connecticut 06611, USA
www.coopersurgical.com | Send Inquiry | Phone: +001-(203)-601-5200
FDA Registration: 1216677 Year Established: 1990 Annual Revenues: USD 100-500 Million Employee Count: ~430 Quality: ISO 9001, CE Certified
Products: Biopsy Punches (FDA Code: FCI), Bone Densitometer (FDA Code: KGI), Bone Densitometry System, Angled Biopsy Punch, Amniotome (FDA Code: HGE), Assisted Reproduction Devices, ...
Cooper Surgical, Inc. provides medical devices and procedure solutions that improve health care delivery to women regardless of the clinical setting. Our product categories are obstetrics, family plan more...
www.coopersurgical.com | Send Inquiry | Phone: +001-(203)-601-5200
FDA Registration: 1216677 Year Established: 1990 Annual Revenues: USD 100-500 Million Employee Count: ~430 Quality: ISO 9001, CE Certified
Products: Biopsy Punches (FDA Code: FCI), Bone Densitometer (FDA Code: KGI), Bone Densitometry System, Angled Biopsy Punch, Amniotome (FDA Code: HGE), Assisted Reproduction Devices, ...
Cooper Surgical, Inc. provides medical devices and procedure solutions that improve health care delivery to women regardless of the clinical setting. Our product categories are obstetrics, family plan more...
Cook Group Incorporated | Address: P.O. Box 489, Bloomington, Indiana 47402-0489, USA
www.cookgroup.com | Phone: +1-(812)-339-2235, 800-457-4500
FDA Registration: 1820334 Employee Count: ~340 Quality: ISO 9000, CE Certified
Products: Ansel Modification, Balloon Catheters, Ansel Modification ANL Curve, Areolar Connective Tissue Grafts In Pediatric, Drug Clinical Trial Service, Centimeter Sizing Catheters, ...
Cook Group Incorporated focuses on the research and product development in minimally invasive medical device technology for diagnostic & therapeutic procedures. Our wire-guided arndt endobronchial blo more...
www.cookgroup.com | Phone: +1-(812)-339-2235, 800-457-4500
FDA Registration: 1820334 Employee Count: ~340 Quality: ISO 9000, CE Certified
Products: Ansel Modification, Balloon Catheters, Ansel Modification ANL Curve, Areolar Connective Tissue Grafts In Pediatric, Drug Clinical Trial Service, Centimeter Sizing Catheters, ...
Cook Group Incorporated focuses on the research and product development in minimally invasive medical device technology for diagnostic & therapeutic procedures. Our wire-guided arndt endobronchial blo more...
Gyrus ACMI | Address: 136 Turnpike Road, Southborough, Massachusetts 01772-2104, USA
medical.olympusamerica.com | Send Inquiry | Phone: +1-(508)-804.2600
FDA Registration: 1519132 Year Established: 1900 Annual Revenues: USD 50-100 Million Employee Count: ~100 Quality: ISO 9000, ISO 9001, ISO 9002, CE Certified
Products: Disposable Injectable Monopolar Needle Electrodes, Polyp SnareT System for Nasal Polyps, Needle Electrode (FDA Code: GXZ), Disposable Concentric Needle Electrodes, Disposable Monopolar Needle Electrodes, Polyp Snare, ...
Gyrus ACMI is engaged in medical device business. We offer urology, gynecology, ENT and anesthesiology products. Our urology products include cystourethroscopes, cystonephroscopes, laparoscopy, percut more...
medical.olympusamerica.com | Send Inquiry | Phone: +1-(508)-804.2600
FDA Registration: 1519132 Year Established: 1900 Annual Revenues: USD 50-100 Million Employee Count: ~100 Quality: ISO 9000, ISO 9001, ISO 9002, CE Certified
Products: Disposable Injectable Monopolar Needle Electrodes, Polyp SnareT System for Nasal Polyps, Needle Electrode (FDA Code: GXZ), Disposable Concentric Needle Electrodes, Disposable Monopolar Needle Electrodes, Polyp Snare, ...
Gyrus ACMI is engaged in medical device business. We offer urology, gynecology, ENT and anesthesiology products. Our urology products include cystourethroscopes, cystonephroscopes, laparoscopy, percut 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...
Urologytech, LLC | Address: 4503 89th St., Lubbock, Texas 79424, USA
urologytech.com | Send Inquiry | Phone: +1-(806)-798-0214, 800-397-3318
Products: General Urology Supplies, Urology Devices, Urology Surgical Instrument, Deep Dorsal Vein Ligator, Manual Gastro-Urology Surgical Instrument (FDA Code: KOA), ...
Urologytech, LLC specializes in the development of medical devices for urological care. We market the Deep Dorsal Vein (DDV) ligator to physicians and hospitals who are in search of a better solution more...
urologytech.com | Send Inquiry | Phone: +1-(806)-798-0214, 800-397-3318
Products: General Urology Supplies, Urology Devices, Urology Surgical Instrument, Deep Dorsal Vein Ligator, Manual Gastro-Urology Surgical Instrument (FDA Code: KOA), ...
Urologytech, LLC specializes in the development of medical devices for urological care. We market the Deep Dorsal Vein (DDV) ligator to physicians and hospitals who are in search of a better solution more...
Lone Star Medical Products, Inc. | Address: 11211 Cash Road, Stafford, Texas 77477, USA
www.lsmp.com | Send Inquiry | Phone: +1-(281)-340-6000, (800)-331-7427
FDA Registration: 1627186 Year Established: 1979 Annual Revenues: USD 5-10 Million Employee Count: ~50 Quality: ISO 9001, CE Certified
Products: Vaginal Retractors (FDA Code: HDL), Self-Retaining Retractors (FDA Code: FFO), Self-Retaining Retractor Systems, Knee Self-Retaining Retractors, Lateral Vaginal Retractor, Surgical Isolation Unit (FDA Code: FRT), ...
Lone Star Medical Products, Inc. manufactures surgical products. We are an ISO: 9001 certified company. We offer products for obstetrics, family planning, general examination, cervical care, incontine more...
www.lsmp.com | Send Inquiry | Phone: +1-(281)-340-6000, (800)-331-7427
FDA Registration: 1627186 Year Established: 1979 Annual Revenues: USD 5-10 Million Employee Count: ~50 Quality: ISO 9001, CE Certified
Products: Vaginal Retractors (FDA Code: HDL), Self-Retaining Retractors (FDA Code: FFO), Self-Retaining Retractor Systems, Knee Self-Retaining Retractors, Lateral Vaginal Retractor, Surgical Isolation Unit (FDA Code: FRT), ...
Lone Star Medical Products, Inc. manufactures surgical products. We are an ISO: 9001 certified company. We offer products for obstetrics, family planning, general examination, cervical care, incontine more...
U.S. Women Institute | Address: 11160 Warner Ave., Suite 117, Fountain Valley, California 92708, USA
Send Inquiry | Phone: +1-(714)-546-3898
Products: General Surgical Instruments, Instruments surgical, Manual Gastro-Urology Surgical Instrument (FDA Code: KOA), ...
U.S. Women Institute is associated with manual gastro-urology surgical instruments. more...
Send Inquiry | Phone: +1-(714)-546-3898
Products: General Surgical Instruments, Instruments surgical, Manual Gastro-Urology Surgical Instrument (FDA Code: KOA), ...
U.S. Women Institute is associated with manual gastro-urology surgical instruments. more...
Applied Medical | Address: 22872 Avenida Empresa, Rancho Santa Margarita, California 92688, USA
www.appliedmedical.com | Send Inquiry | Phone: +1-(949)-713-8000
FDA Registration: 2027111 Year Established: 1987 Annual Revenues: USD 100-500 Million Employee Count: ~1000 Quality: ISO, CE Certified
Products: Thrombectomy Catheter, Embolectomy Catheters (FDA Code: DXE), Arterial Embolectomy Catheter, Laparoscopic Clip Appliers, Insert Clamps, Disposable Laparoscopic Scissors, ...
Applied Medical is associated with clinical areas such as general surgery, urology, vascular, cardiac, colorectal and Ob/Gyn surgery. We have introduced GelPort® laparoscopic system, Kii® abdo more...
www.appliedmedical.com | Send Inquiry | Phone: +1-(949)-713-8000
FDA Registration: 2027111 Year Established: 1987 Annual Revenues: USD 100-500 Million Employee Count: ~1000 Quality: ISO, CE Certified
Products: Thrombectomy Catheter, Embolectomy Catheters (FDA Code: DXE), Arterial Embolectomy Catheter, Laparoscopic Clip Appliers, Insert Clamps, Disposable Laparoscopic Scissors, ...
Applied Medical is associated with clinical areas such as general surgery, urology, vascular, cardiac, colorectal and Ob/Gyn surgery. We have introduced GelPort® laparoscopic system, Kii® abdo more...
Hayden Medical, Inc. | Address: 19425 Soledad Cyn Rd # 411, Santa Clarita, California 91351, USA
www.haydenmedicalinc.com | Send Inquiry | Phone: +1-(877)-296-7205
Products: Curettes, Uterine, Bariatric Instrument System, Hemorrhoidal Ligator (FDA Code: FHN), Manual Gastro-Urology Surgical Instrument (FDA Code: KOA), Hemorrhage Occluder Pins, Bariatric Surgery Instruments, ...
Hayden Medical, Inc. is a supplier of medical and surgical instruments. Our product line includes bariatric instruments, rectal specula, endoscopes, hemorrhoidal ligators, uterine curettes, vaginal re more...
www.haydenmedicalinc.com | Send Inquiry | Phone: +1-(877)-296-7205
Products: Curettes, Uterine, Bariatric Instrument System, Hemorrhoidal Ligator (FDA Code: FHN), Manual Gastro-Urology Surgical Instrument (FDA Code: KOA), Hemorrhage Occluder Pins, Bariatric Surgery Instruments, ...
Hayden Medical, Inc. is a supplier of medical and surgical instruments. Our product line includes bariatric instruments, rectal specula, endoscopes, hemorrhoidal ligators, uterine curettes, vaginal re more...
S.H. Medical Corp. | Address: 3061 Nw 82nd Ave., Miami, Florida 33122, USA
www.shmedical.com | Send Inquiry | Phone: +1-(305)-4062222
FDA Registration: 1064148
Products: Pulse Oximeters, Ultrasounds, Used Surgical Instruments, Endoscopes, Flexible Endoscopes (FDA Code: GCQ), Rigid Endoscopes (FDA Code: GCM), ...
S.H. Medical Corp. distributes & exports new, refurbished and pre-owned medical equipments. We specialize in rigid & flexible endoscopy equipment, endoscopy & surgical instruments, ultrasounds, pulse more...
www.shmedical.com | Send Inquiry | Phone: +1-(305)-4062222
FDA Registration: 1064148
Products: Pulse Oximeters, Ultrasounds, Used Surgical Instruments, Endoscopes, Flexible Endoscopes (FDA Code: GCQ), Rigid Endoscopes (FDA Code: GCM), ...
S.H. Medical Corp. distributes & exports new, refurbished and pre-owned medical equipments. We specialize in rigid & flexible endoscopy equipment, endoscopy & surgical instruments, ultrasounds, pulse more...
Rece International Corp. | Address: 5881 N.W. 151st St., Ste. 111, Miami Lakes, Florida 33014, USA
Phone: +1-(305)-3626555
FDA Registration: 3003965134
Products: Oxygen Masks (FDA Code: BYG), Adult Tongue Depressor (FDA Code: FMA), Hydrophilic Wound Dressings (FDA Code: NAC), Blood Collection Lancet (FDA Code: FMK), Emesis Basin (FDA Code: FNY), Elastic Stocking (FDA Code: ILG), ...
Rece International Corp. provides surgical and medical equipments such as adult tongue depressors, blood collection lancets, elastic stockings, emesis basins, hydrophilic wound dressings, venturi low more...
Phone: +1-(305)-3626555
FDA Registration: 3003965134
Products: Oxygen Masks (FDA Code: BYG), Adult Tongue Depressor (FDA Code: FMA), Hydrophilic Wound Dressings (FDA Code: NAC), Blood Collection Lancet (FDA Code: FMK), Emesis Basin (FDA Code: FNY), Elastic Stocking (FDA Code: ILG), ...
Rece International Corp. provides surgical and medical equipments such as adult tongue depressors, blood collection lancets, elastic stockings, emesis basins, hydrophilic wound dressings, venturi low more...
Flex Medical Inc. | Address: 6128 Curry Ford Rd No. 156, Orlando, Florida 32822, USA
Phone: +1-(407)-306-8318
Products: Manual Gastro-Urology Surgical Instrument (FDA Code: KOA), ...
Flex Medical Inc. specializes in providing manual gastro-urology surgical instruments. more...
Phone: +1-(407)-306-8318
Products: Manual Gastro-Urology Surgical Instrument (FDA Code: KOA), ...
Flex Medical Inc. specializes in providing manual gastro-urology surgical instruments. more...
C. R. Bard, Inc., Bard Medical Div. | Address: 8195 Industrial Blvd., Covington, Georgia 30209, USA
www.bardmedical.com | Send Inquiry | Phone: +1-(770)-784-6100, 800-526-4455
FDA Registration: 3006082230 Quality: ISO 9001 Certified
Products: Arthroscopes (FDA Code: HRX), Adhesive Bandages (FDA Code: KGX), Autotransfusion Apparatus (FDA Code: CAC), Active Electrosurgical Electrode (FDA Code: FAS), AV Shunt Accessories (FDA Code: KNZ), Anti-Infective Latex Foley Catheters, ...
C. R. Bard, Inc., Bard Medical Div. provides products and services that meet the needs of healthcare providers & patients. We specialize in disease state management offering the industry's comprehensi more...
www.bardmedical.com | Send Inquiry | Phone: +1-(770)-784-6100, 800-526-4455
FDA Registration: 3006082230 Quality: ISO 9001 Certified
Products: Arthroscopes (FDA Code: HRX), Adhesive Bandages (FDA Code: KGX), Autotransfusion Apparatus (FDA Code: CAC), Active Electrosurgical Electrode (FDA Code: FAS), AV Shunt Accessories (FDA Code: KNZ), Anti-Infective Latex Foley Catheters, ...
C. R. Bard, Inc., Bard Medical Div. provides products and services that meet the needs of healthcare providers & patients. We specialize in disease state management offering the industry's comprehensi more...
Monarch Medical Products, Inc. | Address: 5890 Bethelview Road, Suite 10-130, Cumming, Georgia 30040, USA
www.monarchmedicalproducts.com | Send Inquiry | Phone: +1-(770)-205-9750
FDA Registration: 3006450414 Year Established: 2007
Products: Endometrial Curettes, Atraumatic Tissue Forceps, Endometrial Suction Curette and Accessories (FDA Code: HHK), Manual Stethoscope (FDA Code: LDE), Atraumatic Grasping Forceps, Manual Gastro-Urology Surgical Instrument (FDA Code: KOA), ...
Monarch Medical Products, Inc. provides German stainless steel surgical instrumentation and single use disposable products designed for women's health. We serve OB/GYN, urogynecology, fertility, hospi more...
www.monarchmedicalproducts.com | Send Inquiry | Phone: +1-(770)-205-9750
FDA Registration: 3006450414 Year Established: 2007
Products: Endometrial Curettes, Atraumatic Tissue Forceps, Endometrial Suction Curette and Accessories (FDA Code: HHK), Manual Stethoscope (FDA Code: LDE), Atraumatic Grasping Forceps, Manual Gastro-Urology Surgical Instrument (FDA Code: KOA), ...
Monarch Medical Products, Inc. provides German stainless steel surgical instrumentation and single use disposable products designed for women's health. We serve OB/GYN, urogynecology, fertility, hospi more...
Pajunk Medical Systems L.P. | Address: 6611 Bay Circle, Suite 100, Norcross, Georgia 30071, USA
www.pajunk.com | Send Inquiry | Phone: +1-(678)-493-6832, 888-972-5865
FDA Registration: 3004076349
Products: Catheters, Diagnostic Instruments, Cannulas, Spinal Instrument, Cannulated Bone Awl, Laparoscopy Instrument/Equipment Cart, Central Nervous System and Components (FDA Code: JXG), ...
Pajunk Medical Systems L.P. is a producer of complete medical systems for the different application-methods in four areas including laparoscopy, regional anaesthesia, biopsy, and dental medicine. The more...
www.pajunk.com | Send Inquiry | Phone: +1-(678)-493-6832, 888-972-5865
FDA Registration: 3004076349
Products: Catheters, Diagnostic Instruments, Cannulas, Spinal Instrument, Cannulated Bone Awl, Laparoscopy Instrument/Equipment Cart, Central Nervous System and Components (FDA Code: JXG), ...
Pajunk Medical Systems L.P. is a producer of complete medical systems for the different application-methods in four areas including laparoscopy, regional anaesthesia, biopsy, and dental medicine. The more...
Sponsored Links
FDA Code / Regulation: KOA / 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.
