FDA 510(k) Application Details - K240037

Device Classification Name	More FDA Info for this Device
510(K) Number	K240037
Device Name	ReviÖ System
Applicant	BlueWind Medical Ltd. 6 Maskit Street Herzliya 4614002 IL Other 510(k) Applications for this Company
Contact	Jason Woehrle Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QXM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/05/2024
Decision Date	05/02/2024
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