K242057
- 510(k) number
- K242057
- Device name
- COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)
- Applicant
- Avanos Medical, Inc. GA · US
- Product code
- GXD — Generator, Lesion, Radiofrequency
- Decision date
- 2024-08-14
- Date received
- 2024-07-15
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K242057
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.