Profile: Cook Urological provides professionals in urological health care with medical products, employing the minimally invasive diagnostic and therapeutic device technologies, already proven clinically in cardiology & radiology. We offer products like Endoscopy, critical care, surgery, urology, women's health, peripheral intervention & artic intervention. We have an additional division, cook OB/GYN® which develop a broad line of products in assisted reproduction, urogynecology, hysteroscopic & laparoscopic surgery, sonohysterography, maternal-fetal medicine & biomaterials for the treatment of incontinence & paravaginal repair.
FDA Registration Number: 1825146
• Hysteroscopic Equipment |
• Incontinence Cuffs |
• Incontinence Management, External Catheters |
• Incontinence Management, Incontinence Cuffs |
• Inflatable Incontinence Cuffs |
• Integral Filiform Urethral Dilator |
• Intermittent Catheters |
• Intestine Bag (FDA Code: KGY / 878.4100) An organ bag is a device that is a flexible plastic bag intended to be used as a temporary receptacle for an organ during surgical procedures to prevent moisture loss. |
• Kidney Internal Splint Stent Set |
• Kidney Stone Extractors |
• Laparoscopic Port Closure Needle |
• Laser Flat Wire Stone Extractor |
• Laser Ureteral Catheter |
• Ligature Carrier (FDA Code: GEJ / 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. |
• Ligature Carrier Set (FDA Code: GEJ / 878.4800) |
• Long Taper Ureteral Dilator |
• Male External Catheters |
• Malleable Tip Filiforms Urethral Dilator |
• Manual/Powered Portable Aspiration Pump (FDA Code: BTA / 878.4780) A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter. |
• Metal Surgical Clips |
• Metal Ureteral Basket Stone Dislodger (FDA Code: FFL / 876.4680) A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger. |
• Metallic Ureteral Stent Set |
• Multi-Length Stent Set |
• Multi-Length Urethral Stents |
• Needle Suspension |
• Needle Suspension Of The Bladder Neck |
• Neonatal Percutaneous Pigtail Nephrostomy Set |
• Nephroscope Set (FDA Code: FGA / 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. |
• Nephrostomy Catheter (FDA Code: LJE) |
• Nephrostomy Tract Dilation Sets |
• Nitinol Helical Stone Extractor |
• Nitinol Stone Extractor |
• Non-Adhesive Silicone Condom Catheter |
• Non-Powered Portable Single Patient Suction Apparatus (FDA Code: GCY / 878.4680) A nonpowered, single patient, portable suction apparatus is a device that consists of a manually operated plastic, disposable evacuation system intended to provide a vacuum for suction drainage of surgical wounds. |
• Nondeflating Foley Catheter |
• Occlusion Equipment, Surgical Clip Appliers |
• Open Biopsy Forceps |
• Open-End Urethral Catheter |
• Open-ended Tapered Tip Urethral Catheter |
• Ostomy Collector (FDA Code: EXB / 876.5900) An ostomy pouch and accessories is a device that consists of a bag that is attached to the patient's skin by an adhesive material and that is intended for use as a receptacle for collection of fecal material or urine following an ileostomy, colostomy, or ureterostomy (a surgically created opening of the small intestine, large intestine, or the ureter on the surface of the body). This generic type of device and its accessories includes the ostomy pouch, ostomy adhesive, the disposable colostomy appliance, ostomy collector, colostomy pouch, urinary ileostomy bag, urine collecting ureterostomy bag, ostomy drainage bag with adhesive, stomal bag, ostomy protector, and the ostomy size selector, but excludes ostomy pouches which incorporate arsenic-containing compounds. |
• Ovarian Biopsy Forceps |
• Pediatric Double Pigtail Stent Sets |
• Pediatric Double Pigtail Stent Sets, Multi-Length |
• Pediatric Double Pigtail Stents |
• Pediatric Firlit-Sugar Intermittent Catheters |
• Pediatric Hydrophilic Personal Catheter |
• Pediatric Intermittent Catheters |
• Pediatric Multi-Length Urethral Stents |
• Pediatric Open-End Urethral Catheters |
• Pediatric Silicone Intermittent Catheter |