510(k) K162648 ยท HIF Insufflator, Laparoscopic
U-Blade Veress Needle
| Applicant | Tianjin Uwell Medical Device Manufacturing Co., Ltd., Tianjin, CN |
| Decision | Substantially Equivalent, Dec 12, 2016 |
| Received | Sep 22, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162648
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.