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510(k) K203066

COOLIEF Cooled Radiofrequency Kit Advanced by Avanos Medical, Inc. — Product Code GXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2020
Date Received
October 9, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Probe, Radiofrequency Lesion
Device Class
Class II
Regulation Number
882.4725
Review Panel
NE
Submission Type

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  • K191293 — LCCS VC-S RF Cannula (January 24, 2020)
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