COOLIEF Cooled Radiofrequency Kit Advanced— 510(k) K203066

Substantially Equivalent

Avanos Medical, Inc.

FDA 510(k) clearance K203066 for COOLIEF Cooled Radiofrequency Kit Advanced, Substantially Equivalent on 2020-12-22. Applicant: Avanos Medical, Inc..

Clearance details

Applicant: Avanos Medical, Inc.
Product code: Code GXI
Advisory panel: Neurology
Date received: 2020-10-09
Decision date: 2020-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpharetta, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GXI

product code GXI

Death: 3
Injury: 171
Total: 174

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.