Taewoong Medical Co., Ltd.
FDA 510(k) & PMA Approved Devices — 10 products
Total Devices10
Categories5
Latest Approval2026-03-13
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K252648 | Niti-S SPAXUS Stent | PCU | 2026-03-13 | View |
| 510(k) | K251123 | Niti-S Biliary Stent; Niti-S Biliary Slim M Stent | FGE | 2025-12-29 | View |
| 510(k) | K243619 | Niti-S Esophageal Stent; Esophageal TTS Stent | ESW | 2025-10-30 | View |
| 510(k) | K250663 | Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent | MUM | 2025-03-31 | View |
| 510(k) | K223067 | Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent | MUM | 2023-06-14 | View |
| 510(k) | K223626 | Niti-S Biliary Speed D Stent | FGE | 2023-05-26 | View |
| 510(k) | K223256 | Optimos Cystotome | KNS | 2023-04-05 | View |
| 510(k) | K221482 | Esophageal TTS Stent | ESW | 2022-06-22 | View |
| 510(k) | K221071 | Niti-S Biliary Slim M Stent | FGE | 2022-06-09 | View |
| 510(k) | K211706 | Esophageal TTS Stent | ESW | 2021-10-08 | View |
No matching devices.