FDA 510(k) Application Details - K212150

Device Classification Name	More FDA Info for this Device
510(K) Number	K212150
Device Name	Exablate Prostate System
Applicant	Insightec, Inc 4851 LBJ Freeway, Suite 400 Dallas, TX 75244 US Other 510(k) Applications for this Company
Contact	Nadir Alikacem Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/09/2021
Decision Date	11/23/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review