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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Radiofrequency Lesion
510(k) Number K163461
Device Name Coolief* Cooled RF Probe
Applicant
Halyard Health, Inc.
5405 Windward Parkway
Alpharetta,  GA  30004
Applicant Contact Monica King
Correspondent
Halyard Health, Inc.
5405 Windward Parkway
Alpharetta,  GA  30004
Correspondent Contact Monica King
Regulation Number882.4725
Classification Product Code
GXI  
Date Received12/09/2016
Decision Date 04/13/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT02343003
Reviewed by Third Party No
Combination Product No
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