510(k) K153124 ยท GEX Powered Laser Surgical Instrument
DuraLazeTM HoLEP Laser Fiber
| Applicant | Medkey, LLC, Bloomington IN, US |
| Decision | Substantially Equivalent, Jul 26, 2016 |
| Received | Oct 29, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153124
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.