Taewoong Medical Co., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 15
- Inspections
- 0
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1229-2020 | Class II | Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B, ES1612B, ES1615B, | October 18, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252648 | Niti-S SPAXUS Stent | March 13, 2026 |
| K251123 | Niti-S Biliary Stent; Niti-S Biliary Slim M Stent | December 29, 2025 |
| K243619 | Niti-S Esophageal Stent; Esophageal TTS Stent | October 30, 2025 |
| K250663 | Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent | March 31, 2025 |
| K223067 | Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent | June 14, 2023 |
| K223626 | Niti-S Biliary Speed D Stent | May 26, 2023 |
| K223256 | Optimos Cystotome | April 5, 2023 |
| K221482 | Esophageal TTS Stent | June 22, 2022 |
| K221071 | Niti-S Biliary Slim M Stent | June 9, 2022 |
| K211706 | Esophageal TTS Stent | October 8, 2021 |
| K123205 | ESOPHAGEAL TTS STENT | October 9, 2013 |
| K113551 | ESOPHAGEAL TTS STENT | February 14, 2012 |
| K080782 | NITI-S ESOPHAGEAL STENT | January 30, 2009 |
| K073667 | NITI-S BILIARY STENT | November 19, 2008 |
| K041648 | NITI-S STENT & INTRODUCER, MODEL EOXXXX | April 28, 2005 |