FDA.reportPublic FDA data

Video capsule endoscopy system capsule

Definition
An electrically-powered, non-digestible capsule containing a video camera designed to pass through the gastrointestinal (GI) tract of a patient after being swallowed or endoscopically introduced, for the internal visualization and examination of the GI tract. It is intended to acquire video images of GI tract sections (e.g., oesophagus, small bowel and colon) and wirelessly transmit the images to a dedicated control unit/monitor (not included) via an external sensor array for examination and data recording. The capsule can be freely mobile or externally controlled by another device (not included); the capsule is excreted from the gut. This is a single-use device.
GUDID devices
29
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
06921010800494 NaviCam Small Bowel Capsule Endoscopy SystemANKON Technologies Co.,Ltd.Capsule/AKES-11SW 2022-12-27
06921010800500 NaviCam Small Bowel Capsule Endoscopy SystemANKON Technologies Co.,Ltd.Capsule/AKES-11SI2022-12-27
08809260260351MiroCam Capusle Endoscope SystemIntroMedic Co., LTD.MC2000-B2018-02-12
08809260260443MiroCam Capsule Endoscope SystemIntroMedic Co., LTD.MC1200-B, MR20002018-03-12
08809260260566MiroCam Capsule Endoscope SystemIntroMedic Co., LTD.MC1200-B2020-09-09
08809260260573MiroCam Capsule Endoscope SystemIntroMedic Co., LTD.MC2000-B2020-09-09
08809260260580MiroCam Capsule Endoscope SystemIntroMedic Co., LTD.MC1600-B2020-09-09
10884521845848PillCam GeniusGiven Imaging, Inc.FGS-06892024-11-29
00810164590114NaviCam Data RecorderANX ROBOTICA CORPSB-US-20032026-02-16
00810164590145NaviCam LocatorANX ROBOTICA CORPSB-US-20062026-02-16
00810164590169NaviCam ESView SoftwareANX ROBOTICA CORPESView 2.X2026-02-16
00810164590794NaviCam ESView 3.XANX ROBOTICA CORPESView 3.X2026-02-16
00810164590008NaviCam SB CapsuleANX ROBOTICA CORPCP-US-70012026-02-09
00810164590039NaviCam SB Capsule/TetherANX ROBOTICA CORPES-US-30012026-02-09
00810164590718NaviCam XS CapsuleANX ROBOTICA CORPCP-US-70092026-02-09
00810164590732NaviCam XS Capsule/TetherANX ROBOTICA CORPES-US-30092026-02-09
10884521846975PillCam GeniusGiven Imaging, Inc.FGS-08062024-11-29
20884521845845PillCam GeniusGiven Imaging, Inc.FGS-06892024-11-29
10884521845831PillCam GeniusGiven Imaging, Inc.FGS-06882024-11-14
16921010800491 NaviCam Small Bowel Capsule Endoscopy SystemANKON Technologies Co.,Ltd.Capsule/AKES-11SW 2022-12-27
16921010800507 NaviCam Small Bowel Capsule Endoscopy SystemANKON Technologies Co.,Ltd.Capsule/AKES-11SI2022-12-27
00850015518287NaviCam TetherANX ROBOTICA CORPCEE-12023-01-05
14953170230995OLYMPUS CAPSULE ENDOSCOPE SYSTEM CAPSULE ENDOSCOPE SET AOLYMPUS MEDICAL SYSTEMS CORP.MAJ-14692021-12-24
00867770000261CapsoCam PlusCAPSOVISION, INC.SV-3KIT2020-12-11
00850015518195NaviCam Capsule Endoscope SystemANX ROBOTICA CORPStomach Capsule/AKEM-11SW2020-12-08
00867770000254CapsoRetrieveCAPSOVISION, INC.CVR12020-09-28
18809260260563MiroCam Capsule Endoscope SystemIntroMedic Co., LTD.MC1200-B2020-09-09
18809260260570MiroCam Capsule Endoscope SystemIntroMedic Co., LTD.MC2000-B2020-09-09
18809260260587MiroCam Capsule Endoscope SystemIntroMedic Co., LTD.MC1600-B2020-09-09