Consulting Wallah › Device Explorer › Endoscopy & surgical instruments › Video capsule endoscopy system capsule
Device Explorer · FDA GUDID · GMDN 38068

Video capsule endoscopy system capsule

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.

US‑registered devices54in commercial distribution
Companies6labelers on GUDID
Single‑use94%of device records
Sterile6%labelled sterile
Prescription80%Rx‑only share
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Share of device records

Given Imaging, Inc.2954%
Intromedic Co., Ltd.1120%
Anx Robotica Corp611%
Capsovision, Inc.59%
Ankon Technologies Co.,Ltd.24%
Olympus Medical Systems Corp.12%

Top labelers

CompanyDevicesShare
Given Imaging, Inc.2954%
Intromedic Co., Ltd.1120%
Anx Robotica Corp611%
Capsovision, Inc.59%
Ankon Technologies Co.,Ltd.24%
Olympus Medical Systems Corp.12%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PillCamPillcamNaviCam Small Bowel Capsule Endoscopy SystemENDOCAPSULE SMALL INTESTINAL CAPSULE ENDOSCOPE SCapsoCam PlusCapsoRetrieveCapsoAccessNaviCam XS Capsule/TetherNaviCam XS CapsuleNaviCam Crossbody BeltNaviCam Stomach Capsule and TetherNaviCam SB Capsule/TetherNaviCam SB CapsulePillCam GeniusMiroCam Capsule Endoscope SystemMiroCam Capusle Endoscope System

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
NEZSYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE24
NEZSystem, Imaging, Gastrointestinal, Wireless, Capsule24
PGDColon capsule imaging system10
QKZMagnetically Maneuvered Capsule Endoscopy System3
QUNTether Accessory For Use In The Gastrointestinal Tract2

GMDN & GCC registration

  • GMDN code 38068 · non‑implantable
  • Single‑use 94% · sterile 6% · Rx‑only 80% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

No closely related category with 50+ devices.

How many video capsule endoscopy system capsule products are registered in the US?

54 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Video capsule endoscopy system capsule", from 6 companies. The largest labeler is Given Imaging, Inc. with 54% of records.

Which FDA product codes apply?

NEZ (SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE), NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule), PGD (Colon capsule imaging system), QKZ (Magnetically Maneuvered Capsule Endoscopy System)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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