510(k) K142113 ยท ODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
ESOPHYX2 HD
| Applicant | Endogastric Solutions, Inc., Gardnerville NV, US |
| Decision | Substantially Equivalent, Sep 30, 2014 |
| Received | Aug 4, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K142113
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.