FDA 510(k) Application Details - K203066

Device Classification Name	Probe, Radiofrequency Lesion   More FDA Info for this Device
510(K) Number	K203066
Device Name	Probe, Radiofrequency Lesion
Applicant	Avanos Medical, Inc. 5405 Windward Parkway, Suite 100 Alpharetta, GA 30004 US Other 510(k) Applications for this Company
Contact	Christian Supina Other 510(k) Applications for this Contact
Regulation Number	882.4725   More FDA Info for this Regulation Number
Classification Product Code	GXI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/09/2020
Decision Date	12/22/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review