Profile: Cook Group Incorporated focuses on the research and product development in minimally invasive medical device technology for diagnostic & therapeutic procedures. Our wire-guided arndt endobronchial blocker set allows one-lung ventilation using a conventional endotrachael tube and a pediatric fiberoptic bronchoscope. Our central venous catheter sets & trays are used for venous pressure monitoring, blood sampling and administration of drugs & fluids.

The company has ~340 employees and is ISO 9000, CE certified.

FDA Registration Number: 1820334

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• Reusable Biopsy Forceps

• Reusable Sphincterotomes

• Rotating Uterine Biopsy Forceps

• Semi Rigid biopsy forceps

• Septostomy Catheter (FDA Code: DXF / 870.5175) A septostomy catheter is a special balloon catheter that is used to create or enlarge the atrial septal defect found in the heart of certain infants.

• Serrated Jaws Carbide Jaw Needle Holder

• Shielded Angiographic Needle

• Short-Term Less Than 30 Days Therapeutic Intravascular Catheter (FDA Code: FOZ / 880.5200) An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

• Shunt System Implantation Instrument (FDA Code: GYK / 882.4545) A shunt system implantation instrument is an instrument used in the implantation of cerebrospinal fluid shunts, and includes tunneling instruments for passing shunt components under the skin.

• Silicone Penrose Drainage Tube

• Silicone T-Y Drainage Tube

• Silicone Y-Drainage Tube

• Single Lumen Hypodermic Needle (FDA Code: FMI / 880.5570) A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

• Single use VacutainerT Needle Holder

• Single-Use Needle Holder

• Sinus Endoscopy, Needle Holders

• Specialized Obstetric-Gynecologic Manual Instrument (FDA Code: KNA / 884.4530) An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:

• Specialty Introducers Keller-Timmermans

• Specialty Introducers Keller-Timmermans, Type Straight

• Specialty Introducers Myocardial Biopsy Design

• Specialty Introducers, No Torque Right 3DRC

• Specialty Introducers, No Torque Right NTR

• Spinal Needles

• Stainless Steel Needle Holders

• Standard Needle Holders

• Standard Oval Biopsy Forceps

• Sterile Single-Use Angiographic Catheter

• Stone Manipulation Forceps

• Stopcock, I.V.Set (FDA Code: FMG / 880.5440) An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

• Straight Carbide Jaw Needle Holder

• Straight Catheter (FDA Code: EZD / 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).

• Subclavian Catheter (FDA Code: LFJ / 876.5540) A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.

• Suction Biopsy Instrument (FDA Code: FCK / 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.

• Suprapubic Catheter and Accessories (FDA Code: KOB / 876.5090) A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.

• Suprapubic Catheter and Tube (FDA Code: FEZ / 876.5090)

• Suprapubic Tube Drainage (FDA Code: FFA / 876.5090)

• Surgical Biliary Catheter (FDA Code: GCA / 876.5010) A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.

• Surgical Mesh (FDA Code: FTM / 878.3300) Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

• Surgical Snare (FDA Code: GAE / 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.

• Temporary Intravascular Occluding Catheter (FDA Code: MJN / 870.4450) A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

• Therapeutic Device Development

• Therapeutic Intravascular Catheter (FDA Code: LJS / 880.5970) A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.

• Thrombectomy Devices, Infusion Catheter

• Thrombolytic Enzyme Infusion System

• Tip Angiographic Catheters

• Titanium Needle Holders

• Tracheal Dilators (FDA Code: KCG / 874.4420)

• Tracheostomy Tube and Cuff (FDA Code: JOH / 868.5800) A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.

• Travel First Aid Kit with Drug (FDA Code: LRR)

• Triangle Needle Holder