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
• Surgical Staplers, Open Clip Appliers |
• Surgical Trays (FDA Code: LRP / 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. |
• Surgical Trays (FDA Code: LRP / 878.4800) |
• Surgical Urine Drain Pouch Set |
• Tipless Stone Extractors |
• Tipped Catheter |
• Titanium Surgical Clip |
• Tooth Retrieval Forceps |
• Transvaginal Needle Suspension |
• Tumor Localization Needle (FDA Code: MIJ / 878.4800) |
• Universal Wedge Urethral Catheter |
• Ureteral Catheter Dilator (FDA Code: EZN / 876.5470) A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture. |
• Ureteral Diversion Stent Set |
• Ureteral Ileal Conduit Stent |
• Ureteral Illuminating Catheter Set - Dual Lumen |
• Ureteral Illuminating Catheter Set - Single Lumen |
• Ureteral Splint (FDA Code: FAD / 876.4620) A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction. |
• Ureteral Stone Pushing Catheter |
• Ureteroscopic Biopsy Forceps |
• Ureteroscopy Stent Set |
• Ureteroscopy, Urethral Access Sheaths |
• Ureterostomy Urinary Collection Bag (FDA Code: EXG / 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. |
• Urethral (Foley) Catheters |
• Urethral Access Sheaths |
• Urethral Catheters (FDA Code: GBM / 876.5130) A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudecatheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use). |
• Urethral Dilation |
• Urethral Dilation Balloon Catheters |
• Urethral Dilators (FDA Code: KOE / 876.5520) A urethral dilator is a device that consists of a slender hollow or solid instrument made of metal, plastic, or other suitable material in a cylindrical form and in a range of sizes and flexibilities. The device may include a mechanism to expand the portion of the device in the urethra and indicate the degree of expansion on a dial. It is used to dilate the urethra. This generic type of device includes the mechanical urethral dilator, urological bougies, metal or plastic urethral sound, urethrometer, filiform, and filiform follower. |
• Urethral Diversion Stents |
• Urethral Sling |
• Urethral Stent Placement |
• Urethral Stents, Endoureterotomy Stents |
• Urinary Incontinence Cuffs |
• Urinary Intermittent Catheters |
• Urinary Leg Bags |
• Urodynamics Catheters |
• Urological Catheters (FDA Code: KOD / 876.5130) |
• Urological Catheters, Intermittent Catheters |
• Urological Fascial Or Renal Dilation |
• Urological Male External Catheters |
• Uterine Manipulator/Injector Cannula (FDA Code: LKF / 884.4530) |
• Uterine Sounds (FDA Code: HHM / 884.4530) |
• Vacuum Collection Bottle (FDA Code: KDQ / 880.6740) A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge). |
• Vaginal Needle Suspension |