510(k) K243619 ยท ESW Prosthesis, Esophageal
Niti-S Esophageal Stent; Esophageal TTS Stent
| Applicant | Taewoong Medical Co., Ltd., Gyeonggi-Do, KR |
| Decision | Substantially Equivalent, Oct 30, 2025 |
| Received | Nov 22, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243619
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.