510(k) K250128 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
Single Use Suction-Evacuation Ureteral Access Sheath
| Applicant | Anhui Happiness Workshop Medical Instruments Co., Ltd., Bengbu, CN |
| Decision | Substantially Equivalent, Sep 19, 2025 |
| Received | Jan 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250128
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.