510(k) K172811 ยท ODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
EsophyX Z, EsophyX2 HD
| Applicant | Endogastric Solutions, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Oct 19, 2017 |
| Received | Sep 18, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172811
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.