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Sign in to claim this brandWhat Taewoong Medical makes
Taewoong Medical produces polymer-metal and bare-metal stents for the oesophagus, biliary system, colon, and duodenum, including self-expanding designs for biliary and oesophageal applications. Their portfolio also includes single-use endoscopic biopsy forceps and mechanical polypectomy snares for tissue removal during gastrointestinal procedures, as well as single-use guidewires for gastro-urological interventions.
The company’s devices are classified under FDA regulations as Class I and Class II, with submissions documented through 510(k) premarket notifications and the FDA’s Unique Device Identifier (UDI) system. Their products are listed in the FDA’s regulatory databases, and the manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Taewoong Medical manufacture?
Taewoong Medical specializes in stents and endoscopic tools for gastrointestinal and biliary procedures. Their product line includes polymer-metal and bare-metal stents for the oesophagus, biliary system, colon, and duodenum, such as self-expanding biliary and oesophageal stents. They also produce single-use endoscopic biopsy forceps (e.g., Optimos™), mechanical polypectomy snares, and single-use guidewires for gastro-urological applications. These devices are designed for interventions like stent placement, tissue sampling, and polyp removal.
Where is Taewoong Medical based, and how does that affect their regulatory oversight?
Taewoong Medical is headquartered in the United States, which means their devices are subject to FDA regulatory requirements. The FDA classifies their products as either Class I (generally low-risk) or Class II (requiring special controls to ensure safety and effectiveness), with submissions tracked through 510(k) premarket notifications and the FDA’s Unique Device Identifier (UDI) system. This ensures compliance with U.S. medical device regulations.
Which regulatory registries or databases list Taewoong Medical’s devices?
Taewoong Medical’s devices are documented in the FDA’s regulatory databases, specifically through 510(k) premarket notifications and the FDA’s Unique Device Identifier (UDI) system. These registries ensure transparency and traceability of their products under U.S. medical device regulations, allowing healthcare providers and regulators to verify compliance and device details.
How are Taewoong Medical’s devices classified under FDA regulations?
Taewoong Medical’s devices are classified under the FDA’s medical device classification system as either Class I or Class II. Class I devices are typically low-risk and may require general controls, while Class II devices require additional regulatory controls to ensure safety and performance. The classification determines the regulatory pathway, such as 510(k) submissions, ensuring proper oversight before market authorization.
What kinds of stents does Taewoong Medical produce, and where are they commonly used?
Taewoong Medical manufactures both polymer-metal and bare-metal stents for various parts of the gastrointestinal and biliary systems. Their portfolio includes oesophageal stents (e.g., Esophageal TTS Stent), biliary stents (e.g., Niti-S Biliary Slim M Stent), colonic stents, and duodenal stents. These stents are commonly used to relieve obstructions, maintain lumen patency, or support tissue in procedures like biliary drainage, oesophageal strictures, or colonic blockages.
AI-generated from registry data and not verified by a human reviewer.
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Catalogue (273)
Page 3 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Esophageal TTS Stent | EST2008F-22 | FDA UDI | Class II | Active |
| Esophageal TTS Stent | EST2008B-22 | FDA UDI | Class II | Active |
| Niti-S Esophageal Stent | E1615 | FDA UDI | Class II | Active |
| Optimos™ Snare | KSN22FHC-10 | FDA UDI | Class I | Active |
| Niti-S Biliary Slim M Stent | BN0805-6 | FDA UDI | Class II | Active |
| Esophageal TTS Stent | EST1806B-22 | FDA UDI | Class II | Active |
| Esophageal TTS Stent | EST2214F-22 | FDA UDI | Class II | Active |
| Esophageal TTS Stent | EST2008B-22 | FDA UDI | Class II | Active |
| Optimos™ Biopsy Forceps | BFR240 | FDA UDI | Class I | Active |
| Niti-S Esophageal Stent | ES1808F | FDA UDI | Class II | Active |
| Optimos™ Biopsy Forceps | BF160N | FDA UDI | Class I | Active |
| Niti-S Biliary Speed D Stent | BDM1004 | FDA UDI | Class II | Active |
| Esophageal TTS Stent | EST2215F-22 | FDA UDI | Class II | Active |
| Niti-S Esophageal Stent | ES1810B | FDA UDI | Class II | Active |
| Niti-S Biliary Slim M Stent | BN0808-6 | FDA UDI | Class II | Active |
| Optimos™ Guidewire | GW2-26S | FDA UDI | Class II | Active |
| Esophageal TTS Stent | EST2214F | FDA UDI | Class II | Active |
| Esophageal TTS Stent | EST1815F-22 | FDA UDI | Class II | Active |
| Optimos™ Biopsy Forceps | BFR160 | FDA UDI | Class I | Active |
| Esophageal TTS Stent | EST1815F | FDA UDI | Class II | Active |
| Esophageal TTS Stent | EST1814B-22 | FDA UDI | Class II | Active |
| Optimos™ Biopsy Forceps | GBFR240 | FDA UDI | Class I | Active |
| Esophageal TTS Stent | EST2015B | FDA UDI | Class II | Active |
| Niti-S Esophageal Stent | E1810 | FDA UDI | Class II | Active |
| Esophageal TTS Stent | EST2210B-22 | FDA UDI | Class II | Active |
| Esophageal TTS Stent | EST1808B-22 | FDA UDI | Class II | Active |
| Niti-S Colonic Comfort Stent | CDT2412N-22 | FDA UDI | Class II | Active |
| Esophageal TTS Stent | EST1810F-22 | FDA UDI | Class II | Active |
| Esophageal TTS Stent | EST2206B | FDA UDI | Class II | Active |
| Optimos™ Biopsy Forceps | BF160 | FDA UDI | Class I | Active |
| Optimos™ Cystotome | OCT1906 | FDA UDI | Class II | Active |
| Esophageal TTS Stent | EST2210F-22 | FDA UDI | Class II | Active |
| Niti-S Biliary Speed D Stent | BDM0808 | FDA UDI | Class II | Active |
| Optimos™ Guidewire | GW2-45A | FDA UDI | Class II | Active |
| Niti-S Esophageal Stent | ES1615F | FDA UDI | Class II | Active |
| Optimos™ Guidewire | GW3-45S | FDA UDI | Class II | Active |
| Esophageal TTS Stent | EST1812F | FDA UDI | Class II | Active |
| Esophageal TTS Stent | EST2010F-22 | FDA UDI | Class II | Active |
| Niti-S Esophageal Stent | ES2010F | FDA UDI | Class II | Active |
| Niti-S Biliary Slim M Stent | BN0809-6 | FDA UDI | Class II | Active |
| Optimos™ Biopsy Forceps | BF240N | FDA UDI | Class I | Active |
| Niti-S Colonic Comfort Stent | CDT2212N-22 | FDA UDI | Class II | Active |
| Esophageal TTS Stent | EST1815F | FDA UDI | Class II | Active |
| Niti-S Esophageal Stent | ES1812B | FDA UDI | Class II | Active |
| Esophageal TTS Stent | EST1814F-22 | FDA UDI | Class II | Active |
| Niti-S Duodenal Comfort Stent | PDT2212N-22 | FDA UDI | Class II | Active |
| Esophageal TTS Stent | EST1812B-22 | FDA UDI | Class II | Active |
| Esophageal TTS Stent | EST2008F | FDA UDI | Class II | Active |
| Esophageal TTS Stent | EST1815B | FDA UDI | Class II | Active |
| Esophageal TTS Stent | EST1808B | FDA UDI | Class II | Active |
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