510(k) K163197 ยท GEX Powered Laser Surgical Instrument
Cook Holmium Laser Fiber
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, May 24, 2017 |
| Received | Nov 15, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163197
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.