510(k) K143645 · ODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
EsophyX® Z Fastener Delivery Device
| Applicant | Endogastric Solutions, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Mar 4, 2015 |
| Received | Dec 22, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143645
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.