FDA 510(k) Applications for Medical Device Product Code "NEZ"
(System, Imaging, Gastrointestinal, Wireless, Capsule)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K221590 | ANKON Technologies Co., Ltd. | NaviCam Small Bowel Capsule Endoscopy System | 12/02/2022 |
| K161773 | CapsoVision, Inc | CapsoCam Plus (SV-3) Capsule Endoscope System | 10/21/2016 |
| K151635 | CapsoVision, Inc. | CapsoCam (SV-1) | 02/09/2016 |
| K183192 | CapsoVision, Inc. | CapsoCam Plus (SV-3) | 04/19/2019 |
| K192662 | CapsoVision, Inc. | CapsoCam Plus (SV-3) Capsule Endoscopy System | 02/14/2020 |
| DEN010002 | 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 |
| K211684 | Given Imaging Ltd. (Medtronic) | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E | 08/27/2021 |
| K230991 | Given Imaging Ltd. (Medtronic) | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E | 06/30/2023 |
| 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 |
| K183053 | Olympus Medical Systems Corp. | Olympus Small Intestinal Capsule Endoscope System | 03/05/2019 |
| 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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