510(k) K253832 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Dilation Balloon Catheter
| Applicant | Mirco-Tech (Nanjing) Co., Ltd., Nanjing, CN |
| Decision | Substantially Equivalent, Apr 24, 2026 |
| Received | Dec 1, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253832
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.