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

FDA 510(k) Number Applicant Device Name Decision Date
K161773 CapsoVision, Inc CapsoCam Plus (SV-3) Capsule Endoscope System 10/21/2016
K151635 CapsoVision, Inc. CapsoCam (SV-1) 02/09/2016
DEN010002 GIVEN IMAGING LTD. GIVEN DIAGNOSTIC IMAGING SYSTEM 08/01/2001
K010312 GIVEN IMAGING LTD. GIVEN DIAGNOSTIC IMAGING SYSTEM 08/01/2001
K032405 GIVEN IMAGING LTD. GIVEN DIAGNOSTIC SYSTEM 10/29/2003
K020341 GIVEN IMAGING LTD. GIVEN DIAGNOSTIC SYSTEM 05/02/2002
K031033 GIVEN IMAGING LTD. GIVEN DIAGNOSTIC SYSTEM 07/01/2003
K053639 GIVEN IMAGING LTD. GIVEN DIAGNOSTIC SYSTEM 05/08/2006
K022362 GIVEN IMAGING LTD. GIVEN DIAGNOSTICS SYSTEM 08/09/2002
K123864 GIVEN IMAGING LTD. GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM 08/12/2013
K101250 GIVEN IMAGING LTD. GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES 03/07/2011
K103088 GIVEN IMAGING LTD. GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT 01/14/2011
K103025 GIVEN IMAGING LTD. GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES 05/13/2011
K140284 GIVEN IMAGING LTD. GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM 12/17/2014
K040248 GIVEN IMAGING LTD. MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM 02/17/2004
K022980 GIVEN IMAGING LTD. MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM 02/27/2003
K062786 GIVEN IMAGING LTD. MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM 10/18/2006
K070475 GIVEN IMAGING LTD. MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM 05/07/2007
K101200 GIVEN IMAGING LTD. PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE 09/30/2010
K091405 GIVEN IMAGING LTD. PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT 07/29/2009
K170210 Given Imaging Ltd. PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 09/01/2017
K170839 Given Imaging Ltd. RAPID Web 05/26/2017
K111450 INTROMEDIC CO., LTD MIROCAM CAPSULE ENDOSCOPE SYSTEM 05/18/2012
K123428 INTROMEDIC CO., LTD MIROCAM CAPSULE ENDOSCOPE SYSTEM 05/20/2013
K134005 INTROMEDIC CO., LTD MIROCAM CAPSULE ENDOSCOPE SYSTEM 07/09/2014
K140751 INTROMEDIC CO., LTD MIROCAM CAPSULE ENDOSCOPE SYSTEM 06/30/2014
K143663 INTROMEDIC CO., LTD MiroCam Capsule Endoscope System 03/17/2015
K180732 IntroMedic Co., Ltd. MiroCam Capsule Endoscope System 11/08/2018
K170438 IntroMedic Co., Ltd. MiroCam Capsule Endoscope System 01/30/2018
K142680 OLYMPUS MEDICAL SYSTEMS CORP. ENDOCAPSULE SOFTWARE 10; ENDOCAPSULE SOFTWARE 10 LIGHT 02/08/2015
K163069 OLYMPUS MEDICAL SYSTEMS CORP. OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM 01/19/2017
K173459 Olympus Medical Systems Corp. Olympus Small Intestinal Capsule Endoscope System 03/13/2018
K123421 OLYMPUS MEDICAL SYSTEMS CORP. OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM 04/29/2013
K090210 OLYMPUS MEDICAL SYSTEMS CORPORATION MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM 07/29/2009
K063259 OLYMPUS MEDICAL SYSTEMS CORPORATION OLYMPUS CAPSULE ENDOSCOPE SYSTEM 09/14/2007
K163495 United States Endoscopy Group, Inc. AdvanCE capsule endoscope delivery device 03/10/2017
K040494 UNITED STATES ENDOSCOPY GROUP, INC. CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143; CAPSULE DELIVERY DEVICE, 210CM, MODEL 711144 06/23/2004


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