Cleared Traditional

COOLIEF Cooled Radiofrequency Kit Advanced

K203066 · Avanos Medical, Inc. · Neurology
Dec 2020
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K203066 is an FDA 510(k) clearance for the COOLIEF Cooled Radiofrequency Kit Advanced, a Probe, Radiofrequency Lesion (Class II — Special Controls, product code GXI), submitted by Avanos Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on December 22, 2020, 74 days after receiving the submission on October 9, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4725.

Submission Details

510(k) Number K203066 FDA.gov
FDA Decision Cleared SESE
Date Received October 09, 2020
Decision Date December 22, 2020
Days to Decision 74 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXI — Probe, Radiofrequency Lesion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4725

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