510(k) K230752 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)
| Applicant | FUJIFILM Healthcare Americas Corporation, Lexington MA, US |
| Decision | Substantially Equivalent, Sep 15, 2023 |
| Received | Mar 17, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230752
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.