FDA.reportPublic FDA data

GIVEN IMAGING LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
97101073003348376GIVEN IMAGING LTD.1N2026-01-012 Hacarmel St. NEW INDUSTRIAL Park, POB 258 Yoqneam Northern IL 2069204

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3321811519345671K240276PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader SoftwareNEZ2024-05-10
3321811200810190K230991PillCam SB 3 capsule endoscopy system, PillCam Software 9.0ENEZ2023-06-30
3321811302954467K211684PillCam SB 3 capsule endoscopy system, PillCam Software 9.0ENEZ2021-08-27
3321811752001067K180171PillCam Patency SystemNSI2018-03-08
3321811510827414K170210PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0NEZ2017-09-01
3321811054419567K153466PillCam COLON 2 Capsule Endoscopy SystemPGD2016-01-14
3321811993921557K151086ManoScan SystemFFX2016-04-28
3321811280280542K140284GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEMNEZ2014-12-17
3321811967077710K123864GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEMNEZ2013-08-12
3321811088392787K102543BRAVO PH MONITORING SYSTEM AND ACCESSORIESFFT2010-12-01
3321811751524723K092342SMARTPILL GI MONITORING SYSTEM, VERSION 2.0NYV2009-10-30
3321811319270287

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NEZ62024-05-10
NSI12018-03-08
FFX12016-04-28
PGD12016-01-14
FFT12010-12-01
NYV12009-10-30

PMN#