Coolief Radiofrequency Generator (CRG) System— 510(k) K192491
Substantially EquivalentAvanos Medical, Inc.
FDA 510(k) clearance K192491 for Coolief Radiofrequency Generator (CRG) System, Substantially Equivalent on 2020-02-21. Applicant: Avanos Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Avanos Medical, Inc.
- Product code
- Code GXD
- Device class
- Class 2
- Regulation
- 21 CFR 882.4400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alpharetta, GA, US
Recent devices under product code GXD
view allMore clearances from Avanos Medical, Inc.
view allAdverse 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 →
Recalls naming K192491
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K192491.
Data sourced from openFDA. This site is unofficial and independent of the FDA.