Coolief Radiofrequency Generator (CRG) System— 510(k) K192491

Substantially Equivalent

Avanos Medical, Inc.

FDA 510(k) clearance K192491 for Coolief Radiofrequency Generator (CRG) System, Substantially Equivalent on 2020-02-21. Applicant: Avanos Medical, Inc..

Clearance details

Applicant: Avanos Medical, Inc.
Product code: Code GXD
Advisory panel: Neurology
Date received: 2019-09-11
Decision date: 2020-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpharetta, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GXD

product code GXD

Injury: 228
Total: 228

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.