510(k) K253568 ยท FDS Gastroscope And Accessories, Flexible/Rigid
Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR
| Applicant | Fujifilm Corporation, Ashigara Kami-Gun, JP |
| Decision | Substantially Equivalent, Feb 6, 2026 |
| Received | Nov 17, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253568
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.