COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)— 510(k) K242057

Name: FDA 510(k) clearance K242057
Creator: U.S. Food and Drug Administration
Published: 2024-08-14

Substantially Equivalent

Avanos Medical, Inc.

FDA 510(k) clearance K242057 for COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R), Substantially Equivalent on 2024-08-14. 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: 2024-07-15
Decision date: 2024-08-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Alpharetta, GA, US

Download summary PDF View on FDA.gov ↗

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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.