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FDA 510(k)

COOLIEF Cooled Radiofrequency Kit

K-Number: K163236 · 2016-12-16

ApplicantHalyard Health, Inc.
Decision Date2016-12-16
Product CodeGXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

COOLIEF Cooled Radiofrequency Kit is a medical device manufactured by Halyard Health, Inc.. It received FDA 510(k) clearance on 2016-12-16 under approval number K163236. 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?

COOLIEF Cooled Radiofrequency Kit is a medical device that received FDA 510(k) clearance on 2016-12-16. It is manufactured by Halyard Health, Inc.. The 510(k) number is K163236.

When was COOLIEF Cooled Radiofrequency Kit approved by the FDA?

COOLIEF Cooled Radiofrequency Kit received FDA 510(k) clearance on 2016-12-16, under approval number K163236.

What company makes COOLIEF Cooled Radiofrequency Kit?

COOLIEF Cooled Radiofrequency Kit is manufactured by Halyard Health, Inc..

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

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

Related Clinical Trials

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

Other Devices by Halyard Health, Inc.

K153255Aero Chrome* Breathable Performance Surgical Gown K162930Aero Chrome* Select Breathable Performance Surgical Gowns K163461Coolief* Cooled RF Probe K173955Mic-Key* SF Over-the-Wire Stoma Measuring Device

Related Devices (Code: GXI)

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. K180369Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)Relievant Medsystems

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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