510(k) K250949 ยท ODC Endoscope Channel Accessory
Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)
| Applicant | Olympus Medical Systems Corporation, Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Jul 16, 2025 |
| Received | Mar 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250949
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2026 | Olympus Corporation of the Americas Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443. Open, Classified |
ODC | None listed |
| Mar 20, 2026 | Olympus Corporation of the Americas Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444. Open, Classified |
ODC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.