510(k) K253646 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
Single Use Distal Cover MAJ-2315 (MAJ-2315)
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Feb 22, 2026 |
| Received | Nov 20, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253646
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.