K242057 is an FDA 510(k) clearance for the COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R). 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 August 14, 2024, 30 days after receiving the submission on July 15, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4400.
| 510(k) Number | K242057 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 2024 |
| Decision Date | August 14, 2024 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | GXD - Generator, Lesion, Radiofrequency |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4400 |