FDA 510(k) Application Details - K153466

Device Classification Name	More FDA Info for this Device
510(K) Number	K153466
Device Name	PillCam COLON 2 Capsule Endoscopy System
Applicant	GIVEN IMAGING LTD. 2 Hacarmel St. NEW INDUSTRIAL Park POB 258 Yoqneam 20962 IL Other 510(k) Applications for this Company
Contact	HILLA DEBBY Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/01/2015
Decision Date	01/14/2016
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