510(k) K162387 ยท GCJ Laparoscope, General & Plastic Surgery
U-IGNITE Bladeless Trocar
| Applicant | Tianjin Uwell Medical Device Manufacturing Co., Ltd., Tianjin, CN |
| Decision | Substantially Equivalent, Jan 11, 2017 |
| Received | Aug 25, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162387
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.