FDA 510(k) Application Details - K183177

Device Classification Name	Probe, Radiofrequency Lesion   More FDA Info for this Device
510(K) Number	K183177
Device Name	Probe, Radiofrequency Lesion
Applicant	Boston Scientific Corporation 25155 Rye Canyon Loop Valencia, CA 91355 US Other 510(k) Applications for this Company
Contact	Adele Shoustal 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	11/16/2018
Decision Date	03/08/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review