510(k) K163236 ยท GXI Probe, Radiofrequency Lesion
COOLIEF Cooled Radiofrequency Kit
| Applicant | Halyard Health, Inc., Alpharetta GA, US |
| Decision | Substantially Equivalent, Dec 16, 2016 |
| Received | Nov 17, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163236
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.