510(k) K253013 ยท GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Disposable Stone Retrieval Balloon Catheter
| Applicant | Zhejiang Soudon Medical Technology Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, May 8, 2026 |
| Received | Sep 19, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253013
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.