510(k) K253132 · FGE Stents, Drains And Dilators For The Biliary Ducts
Single use stone retrieval balloons
| Applicant | Zhejiang Chuangxiang Medical Technology Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Mar 6, 2026 |
| Received | Sep 25, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253132
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.