510(k) K113551 ยท ESW Prosthesis, Esophageal
ESOPHAGEAL TTS STENT
| Applicant | Taewoong Medical Co., Ltd., Alexandria VA, US |
| Decision | Substantially Equivalent, Feb 14, 2012 |
| Received | Dec 1, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113551
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.