K192491

Substantially Equivalent

Coolief Radiofrequency Generator (CRG) System

Applicant: Avanos Medical, Inc.
Product 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

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.