Cleared Special

COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)

K242057 · Avanos Medical, Inc. · Neurology
Aug 2024
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K242057 is an FDA 510(k) clearance for the COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R), a Generator, Lesion, Radiofrequency (Class II — Special Controls, product code GXD), submitted by Avanos Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on August 14, 2024, 30 days after receiving the submission on July 15, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4400.

Submission Details

510(k) Number K242057 FDA.gov
FDA Decision Cleared SESE
Date Received July 15, 2024
Decision Date August 14, 2024
Days to Decision 30 days
Submission Type Special
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code GXD — Generator, Lesion, Radiofrequency
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4400

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