FDA 510(k) Applications Submitted by Given Imaging Ltd.

FDA 510(k) Number Submission Date Device Name Applicant
K140284 02/04/2014 GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM GIVEN IMAGING LTD.
K180171 01/22/2018 PillCam Patency System Given Imaging Ltd.
K170210 01/24/2017 PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 Given Imaging Ltd.
K170839 03/21/2017 RAPID Web Given Imaging Ltd.
K151086 04/22/2015 ManoScan System GIVEN IMAGING LTD.
K153466 12/01/2015 PillCam COLON 2 Capsule Endoscopy System GIVEN IMAGING LTD.
K040248 02/03/2004 MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD.
K041149 05/03/2004 GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE GIVEN IMAGING LTD.
K042960 10/27/2004 GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO GIVEN IMAGING LTD.
K020341 02/01/2002 GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD.
K070475 02/20/2007 MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM GIVEN IMAGING LTD.
K060805 03/24/2006 MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD.
K031033 04/01/2003 GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD.
K071153 04/25/2007 GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE GIVEN IMAGING LTD.
DEN010002 06/11/2001 GIVEN DIAGNOSTIC IMAGING SYSTEM GIVEN IMAGING LTD.
K022362 07/22/2002 GIVEN DIAGNOSTICS SYSTEM GIVEN IMAGING LTD.
K032405 08/04/2003 GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD.
K052184 08/11/2005 GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD.
K062786 09/18/2006 MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD.
K053639 12/30/2005 GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD.
K022980 09/09/2002 MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD.
K090557 03/02/2009 GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM GIVEN IMAGING LTD.
K101200 04/29/2010 PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE GIVEN IMAGING LTD.
K101250 05/04/2010 GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES GIVEN IMAGING LTD.
K091405 05/12/2009 PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT GIVEN IMAGING LTD.
K102543 09/03/2010 BRAVO PH MONITORING SYSTEM AND ACCESSORIES GIVEN IMAGING LTD.
K103025 10/12/2010 GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES GIVEN IMAGING LTD.
K103088 10/19/2010 GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT GIVEN IMAGING LTD.
DEN120023 11/29/2012 GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM GIVEN IMAGING LTD.
K123864 12/17/2012 GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM GIVEN IMAGING LTD.


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