FDA 510(k) Applications for Medical Device Product Code: NSI (System, Imaging, Esophageal, Wireless, Capsule)

FDA 510(k) Applications for Medical Device Product Code "NSI"
(System, Imaging, Esophageal, Wireless, Capsule)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K052184	GIVEN IMAGING LTD.	GIVEN DIAGNOSTIC SYSTEM	12/01/2005
K041149	GIVEN IMAGING LTD.	GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE	10/25/2004
K042960	GIVEN IMAGING LTD.	GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO	11/24/2004
K071153	GIVEN IMAGING LTD.	GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE	06/11/2007
K090557	GIVEN IMAGING LTD.	GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM	09/28/2009
K060805	GIVEN IMAGING LTD.	MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM	05/24/2006
K180171	Given Imaging Ltd.	PillCam Patency System	03/08/2018