Cleared Traditional

COOLIEF Cooled Radiofrequency Kit Advanced (K203066) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K203066 is an FDA 510(k) clearance for the COOLIEF Cooled Radiofrequency Kit Advanced. Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Avanos Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on December 22, 2020 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4725 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Avanos Medical, Inc. devices

Submission Details

510(k) Number K203066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 148d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code GXI Probe, Radiofrequency Lesion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Consultant

Accelerated Device Approval Services
Rafael Aguila

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GXI Probe, Radiofrequency Lesion

All 18
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K203066.
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Vesta RF Cannula
K190259 · Biomerics · Feb 2020
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K190504 · Relievant Medsystems · May 2019