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
• Disposable Urethral Catheters |
• Double Pigtail Ureteral Stent Set |
• Double Pigtail Urethral Stents |
• Double-J Urethral Catheters |
• Drainage Bag Connector - Female |
• Drainage Bag Connector - Male |
• Drainage Pouch Sets |
• Dual Male Luer Lock Adapter |
• Electrohydraulic Lithotriptor (FDA Code: FFK / 876.4480) An electrohydraulic lithotriptor is an AC-powered device used to fragment urinary bladder stones. It consists of a high voltage source connected by a cable to a bipolar electrode that is introduced into the urinary bladder through a cystoscope. The electrode is held against the stone in a water-filled bladder and repeated electrical discharges between the two poles of the electrode cause electrohydraulic shock waves which disintegrate the stone. |
• Electrosurgical Cutting and Coagulation Device (FDA Code: GEI / 878.4400) An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current. |
• Endometrial Aspirator (FDA Code: HFF / 884.1060) An endometrial aspirator is a device designed to remove materials from the endometrium (the mucosal lining of the uterus) by suction with a syringe, bulb and pipette, or catheter. This device is used to study endometrial cytology (cells). |
• Endometrial Brush (FDA Code: HFE / 884.1100) An endometrial brush is a device designed to remove samples of the endometrium (the mucosal lining of the uterus) by brushing its surface. This device is used to study endometrial cytology (cells). |
• Endoscopic Access Overtube (FDA Code: FED / 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. |
• Endoscopic Curved Needle Driver |
• Endoscopic Splash Shield |
• Endoureterotomy Stent Set |
• Endoureterotomy Stents |
• Epispadias Repair, Urethral Stents |
• Epispadias, Pediatric Urethral C-Stents |
• External Catheters |
• Fascial and Renal Dilation |
• Fascial Incising Needle |
• Female External Catheters |
• Female Intermittent Catheters |
• Fiberoptic Illuminator for Endoscope (FDA Code: FFS / 876.1500) |
• Flat Wire Loop Retriever |
• Flat-Wire Percutaneous Stone Extractors |
• Flexible Biopsy Forceps |
• Flexible Rat-Tooth Grasping Forceps |
• Flexible/Rigid Cystoscope and Accessories (FDA Code: FAJ / 876.1500) |
• Flexible/Rigid Ureteroscope and Accessories (FDA Code: FGB / 876.1500) |
• Fluid Evacuator System (FDA Code: FHF / 876.4370) A gastroenterology-urology evacuator is a device used to remove debris and fluids during gastroenterological and urological procedures by drainage, aspiration, or irrigation. This generic type of device includes the fluid evacuator system, manually powered bladder evacuator, and the AC-powered vacuum pump. |
• Foley Catheter Introducer |
• Foley Catheter Kit |
• Foley Catheter Tip Punch |
• Foley Connector - Female |
• Foley Connector - Male |
• Gastro-Urology Endoscopic Injection Needle (FDA Code: FBK / 876.1500) |
• Gastro-Urology Ureteral Catheter (FDA Code: EYB / 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). |
• Gastroenterology-Urology Endoscopic Guidewire (FDA Code: OCY / 876.1500) |
• General & Plastic Surgery Laparoscope (FDA Code: GCJ / 876.1500) |
• General & Plastic Surgery Surgical Microscope (FDA Code: FSO / 878.4700) A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field. |
• General & Plastic Surgery Ureteral Catheter (FDA Code: GBL / 876.5130) |
• Grafts and Matrix |
• Grasping Forceps |
• Helical Stone Extractors |
• Helical Tipless Stone Extractor |
• Hydraulic Cystometric Device (FDA Code: FEN / 876.1620) A urodynamics measurement system is a device used to measure volume and pressure in the urinary bladder when it is filled through a catheter with carbon dioxide or water. The device controls the supply of carbon dioxide or water and may also record the electrical activity of the muscles associated with urination. The device system may include transducers, electronic signal conditioning and display equipment, a catheter withdrawal device to enable a urethral pressure profile to be obtained, and special catheters for urethral profilometry and electrodes for electromyography. This generic type of device includes the cystometric gas (carbon dioxide) device, the cystometric hydrualic device, and the electrical recording cystometer, but excludes any device that uses air to fill the bladder. |
• Hydrophilic Personal Catheter Pediatric |
• Hypospadias and Epispadias Repair Stents |