Coolief Radiofrequency Generator (CRG) System
FDA 510(k) clearance K192491 · decided 2020-02-21
Clearance details
- K-number
- K192491
- Device name
- Coolief Radiofrequency Generator (CRG) System
- Applicant
- Avanos Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-09-11
- Decision date
- 2020-02-21
- Days to decision
- 163 days
- Clearance type
- Traditional
- Product code
- GXD
- Device class
- 2
- Regulation number
- 882.4400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Alpharetta, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF recall (Z-2622-2023) | Avanos Medical, Inc. | 2023-09-21 |