510(k) K161110 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
ClearPetra Suction-Evacuation Sheath
| Applicant | Well Lead Medical Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, Oct 12, 2016 |
| Received | Apr 20, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161110
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.