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FDA 510(k)

COOLIEF Cooled Radiofrequency Kit Advanced

K-Number: K203066 · 2020-12-22

ApplicantAvanos Medical, Inc.
Decision Date2020-12-22
Product CodeGXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

COOLIEF Cooled Radiofrequency Kit Advanced is a medical device manufactured by Avanos Medical, Inc.. It received FDA 510(k) clearance on 2020-12-22 under approval number K203066. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COOLIEF Cooled Radiofrequency Kit Advanced?

COOLIEF Cooled Radiofrequency Kit Advanced is a medical device that received FDA 510(k) clearance on 2020-12-22. It is manufactured by Avanos Medical, Inc.. The 510(k) number is K203066.

When was COOLIEF Cooled Radiofrequency Kit Advanced approved by the FDA?

COOLIEF Cooled Radiofrequency Kit Advanced received FDA 510(k) clearance on 2020-12-22, under approval number K203066.

What company makes COOLIEF Cooled Radiofrequency Kit Advanced?

COOLIEF Cooled Radiofrequency Kit Advanced is manufactured by Avanos Medical, Inc..

What is the FDA product code for COOLIEF Cooled Radiofrequency Kit Advanced?

The FDA product code for COOLIEF Cooled Radiofrequency Kit Advanced is GXI.

Related Clinical Trials

NCT07192172 Enhanced Radiofrequency Ablation for Recurrent HCC Post-TACE Using Twin Internally Cooled-Perfusion Electrodes COMPLETED

Other Devices by Avanos Medical, Inc.

K191340CORTRAK* 2 Equilateral Enteral Access System K192491Coolief Radiofrequency Generator (CRG) System K220588Avanos* CORTRAK* 2 Enteral Access System (EAS) K241185CORGRIP* SR NG/NI Tube Retention System K242057COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) K240965CORTRAK* 2 Enteral Access System (20-0950)

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Related Devices (Code: GXI)

K163236COOLIEF Cooled Radiofrequency KitHalyard Health, Inc. K152642LCCS Disposable RF Electrode, LCCS Reusable RF ElectrodeLccs Products Limited K153272INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument SetRelievant Medsystems K170827INTRACEPT Intraosseous Nerve Ablation SystemRelievant Medsystems K170708OWL RF INSULATED CANNULAEDiros Technology, Inc. K163461Coolief* Cooled RF ProbeHalyard Health, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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