FDA 510(k)

Coolief* Cooled RF Probe

K-Number: K163461 · 2017-04-13

Decision Date2017-04-13

Product CodeGXI

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Coolief* Cooled RF Probe is a medical device manufactured by Halyard Health, Inc.. It received FDA 510(k) clearance on 2017-04-13 under approval number K163461. 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 RF Probe?

Coolief* Cooled RF Probe is a medical device that received FDA 510(k) clearance on 2017-04-13. It is manufactured by Halyard Health, Inc.. The 510(k) number is K163461.

When was Coolief* Cooled RF Probe approved by the FDA?

Coolief* Cooled RF Probe received FDA 510(k) clearance on 2017-04-13, under approval number K163461.

What company makes Coolief* Cooled RF Probe?

Coolief* Cooled RF Probe is manufactured by Halyard Health, Inc..

What is the FDA product code for Coolief* Cooled RF Probe?

The FDA product code for Coolief* Cooled RF Probe is GXI.

Other Devices by Halyard Health, Inc.

K163236COOLIEF Cooled Radiofrequency Kit K153255Aero Chrome* Breathable Performance Surgical Gown K162930Aero Chrome* Select Breathable Performance Surgical Gowns K173955Mic-Key* SF Over-the-Wire Stoma Measuring Device

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

Official Source

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