510(k) K171307 ยท ODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories
| Applicant | Endogastric Solutions, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Jun 22, 2017 |
| Received | May 3, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171307
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.