510(k) K191177 ยท GCJ Laparoscope, General & Plastic Surgery
LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head
| Applicant | Smith and Nephew, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Aug 23, 2019 |
| Received | May 2, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191177
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.