COOLIEF Cooled Radiofrequency Kit

Probe, Radiofrequency Lesion

Halyard Health, Inc.

The following data is part of a premarket notification filed by Halyard Health, Inc. with the FDA for Coolief Cooled Radiofrequency Kit.

Pre-market Notification Details

Device IDK163236
510k NumberK163236
Device Name:COOLIEF Cooled Radiofrequency Kit
ClassificationProbe, Radiofrequency Lesion
Applicant Halyard Health, Inc. 5405 Windward Parkway Alpharetta,  GA  30004
ContactMary Ann B Kinard
CorrespondentDave Yungvirt
THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren,  NJ  07059
Product CodeGXI  
CFR Regulation Number882.4725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2016-11-17
Decision Date2016-12-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00193493469420 K163236 000
00193493469390 K163236 000
00193493469383 K163236 000
00193493469369 K163236 000
00193493469352 K163236 000
00193493469345 K163236 000
00193493469338 K163236 000
00193493469321 K163236 000
00193493469291 K163236 000

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