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

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• 3 Or Three Way Foley Catheter

• Airway Management

• Airway Management, Adult Bronchoscope

• Airway Management, ET Tubes

• Airway Management, Fiber Bronchoscope

• Airway Management, Pediatric Bronchoscope

• Airway Management, Therapeutic Bronchoscope

• Amniotic Fluid Sampler (FDA Code: HIO / 884.1550) The amniotic fluid sampler (amniocentesis tray) is a collection of devices used to aspirate amniotic fluid from the amniotic sac via a transabdominal approach. Components of the amniocentesis tray include a disposable 3 inch 20 gauge needle with stylet and a 30 cc. syringe, as well as the various sample collection accessories, such as vials, specimen containers, medium, drapes, etc. The device is used at 16-18 weeks gestation for antepartum diagnosis of certain congenital abnormalities or anytime after 24 weeks gestation when used to assess fetal maturity.

• Amplatz Renal Dilator Set

• Anesthetic Injection Catheter

• Angled Tip Ureteral Catheter

• Anterior Pelvic Floor Graft

• Assisted Reproduction Accessory (FDA Code: MQG / 884.6120) Assisted reproduction accessories are a group of devices used during assisted reproduction procedures, in conjunction with assisted reproduction needles and/or assisted reproduction catheters, to aspirate, incubate, infuse, and/or maintain temperature. This generic type of device may include:

• Assisted Reproduction Catheter (FDA Code: MQF / 884.6110) Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.

• Assisted Reproduction Microtools (FDA Code: MQH / 884.6130) Assisted reproduction microtools are pipettes or other devices used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.

• Assisted Reproduction Needle (FDA Code: MQE / 884.6100) Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.

• Balloon Inflation Devices

• Balloon Retention Type Catheter (FDA Code: EZL / 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).

• Balloon Urethral Dilator Sets

• Balloon Urethral Dilators

• Biopsy Forceps

• Biopsy Forceps, Internal Jugular Approach 7

• Biopsy Instruments (FDA Code: KNW / 876.1075) A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• Biopsy Instruments (FDA Code: KNW / 876.1075)

• Biopsy Needle Kit (FDA Code: FCG / 876.1075)

• Bladder Access and Drainage, Suprapubic Tube Sets

• Bladder Catheter

• Bladder Control Incontinence cuffs

• Bladder Neck Needle Suspension

• Bladder Pressure Catheter

• Chorionic Villus Sampling Catheter (FDA Code: LLX)

• Coagulating Perforated Resector

• Coaxial Sheath Grasping Forceps

• Cone Tip Ureteral Catheter

• Connecting Flexible Aspirating Tube (FDA Code: BYY / 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).

• Connecting Tubes - One Drainage Bag Connector

• Connecting Tubes - Two Male Luer Locks

• Contrast Injection Line

• Cup Biopsy Forceps

• Cystometric Gas on Hydraulic Device (FDA Code: FAP / 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.

• Cystoscopic Injection Needle

• Cystoscopy Injection Needle

• Cystostomy Catheter Set

• Cytology Brushes

• Deformable Plastic Surgical Clip

• Disposable Biopsy Forceps

• Disposable Inflation Gauge

• Disposable Stone Strainer

• Disposable Surgical Instrument Kit (FDA Code: KDD / 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.

• Disposable Two-Part Trocar Needle