FDA 510(k) Application Details - K223031

Device Classification Name	More FDA Info for this Device
510(K) Number	K223031
Device Name	Vibrant System
Applicant	Vibrant Ltd. Hakochav P.O. Box 516 Yokneam 2069206 IL Other 510(k) Applications for this Company
Contact	Martha Bezalel Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2022
Decision Date	01/13/2023
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