FDA 510(k) Application Details - K211684

Device Classification Name	System, Imaging, Gastrointestinal, Wireless, Capsule   More FDA Info for this Device
510(K) Number	K211684
Device Name	System, Imaging, Gastrointestinal, Wireless, Capsule
Applicant	Given Imaging Ltd. (Medtronic) 2 Hacarmel St. New Industrial Park, PO Box 258 Yoqneam 20692 IL Other 510(k) Applications for this Company
Contact	Efrat Shamgar Other 510(k) Applications for this Contact
Regulation Number	876.1300   More FDA Info for this Regulation Number
Classification Product Code	NEZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2021
Decision Date	08/27/2021
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