510(k) K160960 · ODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
EsophyX® Z Device with SerosaFuse Fasteners and Accessories
| Applicant | Endogastric Solutions, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, May 1, 2016 |
| Received | Apr 5, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160960
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.