510(k) K250695 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
Single-use Ureteral Access Sheath
| Applicant | Shenzhen HugeMed Medical Technical Development Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Jul 8, 2025 |
| Received | Mar 7, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250695
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.