Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Halyard Health, Inc.. It received FDA 510(k) clearance on 2016-12-16 under 510(k) 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. The listed applicant is Halyard Health, Inc.. The 510(k) number is K163236.

When did COOLIEF Cooled Radiofrequency Kit receive FDA 510(k) clearance?

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

Who is the listed applicant for COOLIEF Cooled Radiofrequency Kit?

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 Radiofrequency Kit?

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

Other records listing Halyard Health, Inc. as applicant

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.

K181360ON-Q* Pump with BolusK180646Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy DrugsK173955Mic-Key* SF Over-the-Wire Stoma Measuring DeviceK162930Aero Chrome* Select Breathable Performance Surgical GownsK163461Coolief* Cooled RF ProbeK161232ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit

View all 10 devices →

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.

↑