510(k) K260521 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)
| Applicant | Zhuhai Pusen Medical Technology Co., Ltd., Zhuhai, CN |
| Decision | Substantially Equivalent, Apr 6, 2026 |
| Received | Feb 17, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260521
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.