Cleared Traditional

Coolief Radiofrequency Generator (CRG) System (K192491) - FDA 510(k) Clearance

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

K192491 · Avanos Medical, Inc. · Neurology device
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Feb 2020
Decision
163d
Days
Class 2
Risk

K192491 is an FDA 510(k) clearance for the Coolief Radiofrequency Generator (CRG) System. Classified as Generator, Lesion, Radiofrequency (product code GXD), Class II - Special Controls.

Submitted by Avanos Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on February 21, 2020 after a review of 163 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4400 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Avanos Medical, Inc. devices

Submission Details

510(k) Number K192491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2019
Decision Date February 21, 2020
Days to Decision 163 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 148d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXD Generator, Lesion, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4400
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 Peers - GXD Generator, Lesion, Radiofrequency

All 36
Devices cleared under the same product code (GXD) and FDA review panel - the closest regulatory comparables to K192491.
GX1 Radiofrequency Generator Kit (RFG-X1-120V)
K251247 · Boston Scientific Neuromodulation Corporation · Aug 2025
COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)
K242057 · Avanos Medical, Inc. · Aug 2024
Racz Neurostat RF Generator
K232632 · Epimed International · May 2024
OneRF Ablation System
K231675 · Neuroone Medical Technologies Corp. · Dec 2023
APEX 6
K220122 · Rf Innovations, Inc. · Mar 2023
Abbott Medical Grounding Pad, model RF-DGP-IS
K203293 · Abbott Medical · Jan 2022