COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)— 510(k) K242057
Substantially EquivalentAvanos Medical, Inc.
FDA 510(k) clearance K242057 for COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R), Substantially Equivalent on 2024-08-14. Applicant: Avanos Medical, Inc..
Clearance details
- Applicant
- Avanos Medical, Inc.
- Product code
- Code GXD
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Alpharetta, GA, US
Adverse events under product code GXD
product code GXD- Injury
- 228
- Total
- 228
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.