Profile: Uroplasty BV manufactures and markets a platform of minimally invasive products to treat voiding dysfunctions, including urinary & fecal incontinence, overactive bladder and vesicoureteral reflux. Our I-STOP™ mid-urethral sling aids in the treatment of stress urinary incontinence. Our urgent PC system is an effective, office-based method of treating overactive bladder symptoms that include urinary urgency, urinary frequency and urge incontinence.
FDA Registration Number: 3002647932
48 Products/Services (Click for related suppliers)
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• Aesthetic Dermal Implant (FDA Code: LMH) |
• Blood Collection Sets with Needle Holder |
• Blood Needle Holder Systems |
• Coronary Needle Holders |
• Cosmetic Surgery, Needle Holder (Serrated) |
• Crile Wood Needle Holder |
• Curved Carbide Jaw Needle Holder |
• Disposable Aspiration and Injection Needle (FDA Code: GAA / 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. |
• Forceps Needle Holders |
• Gastro-Urology Endoscopic Injection Needle (FDA Code: FBK / 876.1500) An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. |
• Gastroenterologic Needle Holder (FDA Code: FHQ / 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. |
• Hexagonal Needle Holder |
• Implanted Fecal Incontinence Device (FDA Code: MIP) |
• Injectable Bulking Agent (FDA Code: LNM) |
• Left Hand Needle Holders |
• Manual Gastro-Urology Surgical Instrument (FDA Code: KOA / 876.4730) |
• Manual Periurethral Bulking Agents |
• Micro Castroviejo Needle Holder with Stopper |
• Micro Needle Holder |
• Micro Needle Holder Round Handle |
• Micro Needle Holders with Flat Handles |
• Micro Needle Holders with Lightweight Plastic Handles |
• Micro Spring Handle Needle Holder |
• Microvascular Needle Holders |
• Needle Holder For 10mm Diameter Tubes |
• Needle Holder Round |
• Needle Holders & Scissors |
• Needle Holders Repair Service |
• Needle Holders with TC-Inserts |
• Needle Holders with Tungsten Carbide Inserts |
• Non-Implanted Peripheral Nerve Stimulator For Pelvic Floor Dysfunction (FDA Code: NAM / 876.5310) A nonimplanted, peripheral electrical continence device is a device that consists of an electrode that is connected by an electrical cable to a battery-powered pulse source. The electrode is placed onto or inserted into the body at a peripheral location and used to stimulate the nerves associated with pelvic floor function to maintain urinary continence. When necessary, the electrode may be removed by the user. |
• Ophthalmology Needle Holders |
• Pediatric Tube Needle Holder Adapter |
• Periurethral Bulking Agents |
• Periurethral Bulking Agents Injectable |
• Serrated Jaws Carbide Jaw Needle Holder |
• Single use VacutainerT Needle Holder |
• Single-Use Needle Holder |
• Sinus Endoscopy, Needle Holders |
• Stainless Steel Needle Holders |
• Standard Needle Holders |
• Straight Carbide Jaw Needle Holder |
• Titanium Needle Holders |
• Triangle Needle Holder |
• Tungsten Carbide Needle Holders |
• Vascular Needle Holder |
• Vertical Needle Holder |
• Vocal Cord Medialization System (FDA Code: MIX / 874.3620) Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene. |