Profile: Northgate Technologies, Inc. (NORTECH) designs, develops, manufactures and markets software controlled medical devices, related specialty products & associated consumable products in the fields of urology, general surgery, gynecology & arthroscopy. Our product line comprises of insufflation systems, tubing sets, fluid management and stone management. Our Hydrotower™ system serves as an alternative to a gravity driven system or to a pump (which infuses fluids directly into the patient). It offers constant pressure & flow rates once the system is set-up for the procedure, and reduces the risk of running out of fluid during a procedure since the source bags continuously fill the tower bag. It also eliminates the need to call on operating room staff to raise or lower the fluid bags when more pressure or flow is needed. Our Autolith® lithotripter is indicated for urinary and biliary stone treatment.
The company was founded in 1972, has revenues of USD 1-5 Million, has ~40 employees and is ISO 13485, CE certified.
FDA Registration Number: 1450997
14 Products/Services (Click for related suppliers)
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• Direct Patient Interface Nebulizer (FDA Code: CAF / 868.5630) A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device. |
• 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. |
• Endoscope Accessories (FDA Code: KOG) |
• Fluid Management Systems |
• Gastro-Urology Evacuator (FDA Code: KQT / 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. |
• General & Plastic Surgery Laparoscope (FDA Code: GCJ / 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. |
• Hysteroscopic Insufflator (FDA Code: HIG / 884.1700) A hysteroscopic insufflator is a device designed to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope. |
• Insuffation Tubing Sets |
• Intravenous Administration Kit (FDA Code: FPA / 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. |
• Laparoscopic Insufflation Systems |
• Laparoscopic Insufflation Tubing/Tubing With Filter (FDA Code: NKC / 884.1730) A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it. |
• Laparoscopic Insufflator (FDA Code: HIF / 884.1730) |
• Spirometry Peak Flow Meter (FDA Code: BZH / 868.1860) A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate. |
• Urological Irrigation System (FDA Code: LJH / 876.5130) |