510(k) K203066 ยท GXI Probe, Radiofrequency Lesion
COOLIEF Cooled Radiofrequency Kit Advanced
| Applicant | Avanos Medical, Inc., Alpharetta GA, US |
| Decision | Substantially Equivalent, Dec 22, 2020 |
| Received | Oct 9, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203066
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.