510(k) K163461 ยท GXI Probe, Radiofrequency Lesion
Coolief* Cooled RF Probe
| Applicant | Halyard Health, Inc., Alpharetta GA, US |
| Decision | Substantially Equivalent, Apr 13, 2017 |
| Received | Dec 9, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163461
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.