K192491 is an FDA 510(k) clearance for the Coolief Radiofrequency Generator (CRG) System. This device is classified as a Generator, Lesion, Radiofrequency (Class II - Special Controls, product code GXD).
Submitted by Avanos Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on February 21, 2020, 163 days after receiving the submission on September 11, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4400.
| 510(k) Number | K192491 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 2019 |
| Decision Date | February 21, 2020 |
| Days to Decision | 163 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXD - Generator, Lesion, Radiofrequency |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4400 |