510(k) K151084 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
Well Lead Ureteral Access Sheath
| Applicant | Well Lead Medical Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, Jan 7, 2016 |
| Received | Apr 22, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151084
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.