510(k) K251229 · FGE Stents, Drains And Dilators For The Biliary Ducts
EndoFixTissue Fixation System
| Applicant | Softac Medical Technologies, Plainville MA, US |
| Decision | Substantially Equivalent, Aug 20, 2025 |
| Received | Apr 21, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251229
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.