510(k) K243091 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
Over-tube (TR-1108A)
| Applicant | Fujifilm Corporation, Ashigara Kami-Gun, JP |
| Decision | Substantially Equivalent, Nov 1, 2024 |
| Received | Sep 30, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K243091
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.