510(k) K192491 ยท GXD Generator, Lesion, Radiofrequency
Coolief Radiofrequency Generator (CRG) System
| Applicant | Avanos Medical, Inc., Alpharetta GA, US |
| Decision | Substantially Equivalent, Feb 21, 2020 |
| Received | Sep 11, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192491
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2023 | Avanos Medical, Inc. COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF channels to be activated individually or altogether. The system is controlled via a Completed |
GXD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.