510(k) K250409 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA)
| Applicant | Olympus Medical Systems Corporation, Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Oct 21, 2025 |
| Received | Feb 13, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250409
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.