COOLIEF Cooled Radiofrequency Kit Advanced

Probe, Radiofrequency Lesion

Avanos Medical, Inc.

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

Pre-market Notification Details

Device IDK203066
510k NumberK203066
Device Name:COOLIEF Cooled Radiofrequency Kit Advanced
ClassificationProbe, Radiofrequency Lesion
Applicant Avanos Medical, Inc. 5405 Windward Parkway, Suite 100 Alpharetta,  GA  30004
ContactChristian Supina
CorrespondentRafael Aguila
Accelerated Device Approval Services 6800 S.W. 40th Street, Ste. 403 Ludlum,  FL  33155
Product CodeGXI  
CFR Regulation Number882.4725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-10-09
Decision Date2020-12-22
Summary:summary

NIH GUDID Devices

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