510(k) K251997 ยท OCX Endoscopic Irrigation/Suction System
Single-Use Biopsy Valve (MAJ-1555)
| Applicant | Olympus Medical Systems Corporation, Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Sep 25, 2025 |
| Received | Jun 27, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251997
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.