Company · KR
Taewoong Medical Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2026. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (3 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 21, 2026 | K260962 | Sphincterotome Taewoong Medical Co., Ltd., KR | KNS |
| Mar 13, 2026 | K252648 | Niti-S SPAXUS Stent Taewoong Medical Co., Ltd., KR | PCU |
| Dec 29, 2025 | K251123 | Niti-S Biliary Stent; Niti-S Biliary Slim M Stent Taewoong Medical Co., Ltd., KR | FGE |
| Oct 30, 2025 | K243619 | Niti-S Esophageal Stent; Esophageal TTS Stent Taewoong Medical Co., Ltd., KR | ESW |
| Mar 31, 2025 | K250663 | Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent Taewoong Medical Co., Ltd., KR | MUM |
| Mar 22, 2024 | K240522 | Esophageal TTS Stent Taewoong Medical, KR | ESW |
| Jun 14, 2023 | K223067 | Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent Taewoong Medical Co., Ltd., KR | MUM |
| May 26, 2023 | K223626 | Niti-S Biliary Speed D Stent Taewoong Medical Co., Ltd., KR | FGE |
| Apr 5, 2023 | K223256 | Optimos™ Cystotome Taewoong Medical Co., Ltd., KR | KNS |
| Jun 22, 2022 | K221482 | Esophageal TTS Stent Taewoong Medical Co., Ltd., KR | ESW |
| Jun 9, 2022 | K221071 | Niti-S Biliary Slim M Stent Taewoong Medical Co., Ltd., KR | FGE |
| Oct 8, 2021 | K211706 | Esophageal TTS Stent Taewoong Medical Co., Ltd., KR | ESW |
| Oct 9, 2013 | K123205 | ESOPHAGEAL TTS STENT Taewoong Medical Co., Ltd. | ESW |
| Feb 14, 2012 | K113551 | ESOPHAGEAL TTS STENT Taewoong Medical Co., Ltd. | ESW |
| Jan 30, 2009 | K080782 | NITI-S ESOPHAGEAL STENT Taewoong Medical Co., Ltd. | ESW |
| Nov 19, 2008 | K073667 | NITI-S BILIARY STENT Taewoong Medical Co., Ltd. | FGE |
| Apr 28, 2005 | K041648 | NITI-S STENT & INTRODUCER, MODEL EOXXXX Taewoong Medical Co., Ltd. | ESW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 18, 2019 | Taewoong Medical Co., Ltd. Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B, ES1612B, ES1615B, ES1810B, ES1812B, ES1815B, ES1610F, ES1612F, ES1615F, ES2006F, ES2008F, ES2010F;
Esophageal TTS St Terminated |
ESW | K080782 K113551 +1 |