510(k) K250585 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
LumenaTM Ureteral Access Sheath
| Applicant | Cathegenix (Xiamen) Co., Ltd., Xiamen, CN |
| Decision | Substantially Equivalent, Jun 27, 2025 |
| Received | Feb 27, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250585
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.