510(k) K253987 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
BARE Wireguided Balloon Dilation Catheter (1235)
| Applicant | GIE Medical, Brooklyn Park MN, US |
| Decision | Substantially Equivalent, Mar 13, 2026 |
| Received | Dec 12, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253987
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.