FDA 510(k) Application Details - K223595

Device Classification Name	More FDA Info for this Device
510(K) Number	K223595
Device Name	vPATCH
Applicant	Virility Medical, Ltd. 24 Hanagar St., Suite 106 Hod-Hasharon 4527713 IL Other 510(k) Applications for this Company
Contact	Tal Golan Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QRC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/02/2022
Decision Date	05/01/2023
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