Profile: Taewoong Medical Co., Ltd develops stents. Our GI stents are used to maintain or restore the lumen of hollow organs, vessels, and ducts. Non-vascular stents are devices to create an artificial pathway, open for hollow lumen organs that are closed or obstructed due to cancerous lesions or benign disease. Our Biliary stents are tubular devices, designed to maintain or enhance the patency of a lumen. The Niti-S Biliary stent is intended for maintaining luminal patency in biliary strictures caused by malignant or benign disease. The Niti-S Esophageal stent consists of implantable metallic stent and introducer system. Our Niti-S pyloric/duodenal stent is designed for palliation of malignant gastric outlet obstruction in the antrum, proximal small bowel, and gastro-enteral anastomosis.
FDA Registration Number: 3003902943
US Agent: Calley A. Herzog / Biologics Consulting Group. Inc
Phone: +1-(720)-883-3633 Fax: +1-(703)-548-7457 E-Mail:
12 Products/Services (Click for related suppliers)
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• Airway Stents |
• Biliary Stents |
• Colonic Stent |
• Coronary Covered Stent (FDA Code: NIV) |
• Diagnostic Biliary Catheter (FDA Code: FGE / 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. |
• Duodenal Stent |
• Endoscopy Accessories |
• Esophageal Prosthesis (FDA Code: ESW / 878.3610) An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system. |
• Esophageal Stents |
• Metal Ureteral Basket Stone Dislodger (FDA Code: FFL / 876.4680) A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger. |
• Non-Electric Biopsy Forceps (FDA Code: FCL / 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. |
• Vascular Stent |