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FDA 510(k)

Coolief* Cooled RF Probe

K-Number: K163461 · 2017-04-13

ApplicantHalyard Health, Inc.
Decision Date2017-04-13
Product CodeGXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Coolief* Cooled RF Probe is the device name listed in this FDA 510(k) record. The listed applicant is Halyard Health, Inc.. It received FDA 510(k) clearance on 2017-04-13 under 510(k) 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. The listed applicant is Halyard Health, Inc.. The 510(k) number is K163461.

When did Coolief* Cooled RF Probe receive FDA 510(k) clearance?

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

Who is the listed applicant for Coolief* Cooled RF Probe?

The FDA 510(k) record lists Halyard Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Halyard Health, Inc. as applicant

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Related Devices (Code: GXI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253907Disposable Radiofrequency CannulaABBOTT MEDICALK251802STAR RF Ablation SystemMerit Medical Systems, Inc.K251243OneRF Trigeminal Nerve Radiofrequency ProbesNeuroone Medical Technologies Corp.K242841Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)ABBOTT MEDICALK250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)Stryker InstrumentsK241367RF CannulaShanghai Samedical & Plastic Instruments Co., Ltd.

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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