Cleared Traditional

Coolief Radiofrequency Generator (CRG) System

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

About This 510(k) Submission

K192491 is an FDA 510(k) clearance for the Coolief Radiofrequency Generator (CRG) System, 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 February 21, 2020, 163 days after receiving the submission on September 11, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4400.

Submission Details

510(k) Number K192491 FDA.gov
FDA Decision Cleared 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

Device Classification

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

Similar Devices — GXD Generator, Lesion, Radiofrequency

All 36
GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)
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

More from Avanos Medical, Inc.

View all
Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, La
K243572 · IRP · Jan 2025
CORGRIP* SR NG/NI Tube Retention System
K241185 · KNT · Oct 2024
COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)
K242057 · GXD · Aug 2024
CORTRAK* 2 Enteral Access System (20-0950)
K240965 · KNT · Jun 2024
Avanos* CORTRAK* 2 Enteral Access System (EAS)
K220588 · KNT · Apr 2022