FDA.reportPublic FDA data

MiroCam Capsule Endoscope System

Primary DI
18809260260587
Brand
MiroCam Capsule Endoscope System
Company
IntroMedic Co., LTD.
Model
MC1600-B
Published
2020-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NEZSystem, Imaging, Gastrointestinal, Wireless, Capsule

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEZSystem, Imaging, Gastrointestinal, Wireless, CapsuleGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180732000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180732000MiroCam Capsule Endoscope SystemIntromedic Co., Ltd.2018-11-08NEZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18809260260587PackageGS120In Commercial Distribution
08809260260580PrimaryGS10
08809260260122Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880926026058718809260260587
08809260260580088092602605808809260260580
08809260260122088092602601228809260260122

GMDN Terms#

Term, Definition table
TermDefinition
Video capsule endoscopy system capsuleAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
631065794
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809260260566MiroCam Capsule Endoscope SystemMC1200-B2020-09-09
08809260260573MiroCam Capsule Endoscope SystemMC2000-B2020-09-09
08809260260580MiroCam Capsule Endoscope SystemMC1600-B2020-09-09
18809260260563MiroCam Capsule Endoscope SystemMC1200-B2020-09-09
18809260260570MiroCam Capsule Endoscope SystemMC2000-B2020-09-09
08809260260351MiroCam Capusle Endoscope SystemMC2000-B2018-02-12
08809260260443MiroCam Capsule Endoscope SystemMC1200-B, MR20002018-03-12
08809260260191MiroCam Capsule Endoscope SystemMR20002018-02-12
08809260260269MiroCam Capsule Endoscope SystemMC1000-B2017-01-31
08809260260290MiroCam Capsule Endoscope SystemMC1200-B2017-01-31
08809260260436MiroCam Capusle Endoscope System MC2000-B, MR20002018-02-12
08809260260320MiroCam Capsule Endoscope SystemMC1600-B2019-06-17
08809260260498MiroCam Capsule Endoscope SystemMC1600-B, MR20002019-06-17
18809260260358MiroCam Capusle Endoscope SystemMC2000-B2018-02-12
98809260260446MiroCam Capsule Endoscope SystemMC1200-B, MR20002018-03-12
08809260260184MiroCam Capsule Endoscope SystemMR11002017-01-31
08809260260375MiroCam Capsule Endoscope SystemMC1000-B, MR11002017-01-31
08809260260382MiroCam Capsule Endoscope SystemMC1200-B, MR11002017-01-31
08809260260405MiroCam Capsule Endoscope SystemMR1000-D(M)2017-12-05
08809260260412MiroCam Capsule Endoscope SystemMR1000-D(L)2017-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810164590145NaviCam LocatorANX ROBOTICA CORPNEZ2026-02-16
00810164590169NaviCam ESView SoftwareANX ROBOTICA CORPNEZ2026-02-16
00810164590794NaviCam ESView 3.XANX ROBOTICA CORPNEZ2026-02-16
00810164590008NaviCam SB CapsuleANX ROBOTICA CORPNEZ2026-02-09
00810164590039NaviCam SB Capsule/TetherANX ROBOTICA CORPNEZ2026-02-09
00810164590718NaviCam XS CapsuleANX ROBOTICA CORPNEZ2026-02-09
00810164590732NaviCam XS Capsule/TetherANX ROBOTICA CORPNEZ2026-02-09
00867770000278CE Deliver CAPSOVISION, INC.NEZ2026-01-08
00867770000285CE Deliver CAPSOVISION, INC.NEZ2026-01-08
10884521845848PillCam GeniusGiven Imaging, Inc.NEZ2024-11-29
20884521845845PillCam GeniusGiven Imaging, Inc.NEZ2024-11-29
10884521846975PillCam GeniusGiven Imaging, Inc.NEZ2024-11-29
10884521845831PillCam GeniusGiven Imaging, Inc.NEZ2024-11-14
10884521845916PillCamGiven Imaging, Inc.NEZ2024-11-14
10884521845923PillCamGiven Imaging, Inc.NEZ2024-11-14
10884521836181PillCamGiven Imaging, Inc.NEZ2023-10-05
04953170214288RECORDER UNIT HARNESSOLYMPUS MEDICAL SYSTEMS CORP.NEZ2023-06-21
04953170231001CAPSULE ENDOSCOPE SYSTEM A-SETOLYMPUS MEDICAL SYSTEMS CORP.NEZ2023-06-21
04953170231032ANTENNA LEAD SETOLYMPUS MEDICAL SYSTEMS CORP.NEZ2023-06-21
04953170244506RECORDER UNITOLYMPUS MEDICAL SYSTEMS CORP.NEZ2023-06-21
04953170245657RECORDER UNIT CRADLEOLYMPUS MEDICAL SYSTEMS CORP.NEZ2023-06-21
04953170360817ENDOCAPSULE SOFTWARE 10 SOFT SERVER-CLIENTOLYMPUS MEDICAL SYSTEMS CORP.NEZ2023-06-21
04953170360824ENDOCAPSULE SOFTWARE 10 SOFTWARE CLIENTOLYMPUS MEDICAL SYSTEMS CORP.NEZ2023-06-21
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06921010800500 NaviCam Small Bowel Capsule Endoscopy SystemANKON Technologies Co.,Ltd.NEZ2022-12-27
16921010800491 NaviCam Small Bowel Capsule Endoscopy SystemANKON Technologies Co.,Ltd.NEZ2022-12-27
16921010800507 NaviCam Small Bowel Capsule Endoscopy SystemANKON Technologies Co.,Ltd.NEZ2022-12-27
06921010800517 NaviCam Small Bowel Capsule Endoscopy SystemANKON Technologies Co.,Ltd.NEZ2022-12-27
06921010800524 NaviCam Small Bowel Capsule Endoscopy SystemANKON Technologies Co.,Ltd.NEZ2022-12-27