510(k) K152182 ยท FDS Gastroscope And Accessories, Flexible/Rigid
Fuse Gastroscopy System
| Applicant | Endochoice, Inc., Alpharetta GA, US |
| Decision | Substantially Equivalent, Dec 10, 2015 |
| Received | Aug 5, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152182
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.