FDA.reportPublic FDA data

MiroCam Capusle Endoscope System

Primary DI
18809260260358
Brand
MiroCam Capusle Endoscope System
Company
IntroMedic Co., LTD.
Model
MC2000-B
Published
2018-02-12
Public version status
Update
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
K170438000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170438000MiroCam Capsule Endoscope SystemIntromedic Co., Ltd.2018-01-30NEZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18809260260358PackageGS116In Commercial Distribution
08809260260351PrimaryGS10
08809260260153Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880926026035818809260260358
08809260260351088092602603518809260260351
08809260260153088092602601538809260260153

GMDN Terms#

Term, Definition table
TermDefinition
Video capsule endoscopy system capsuleAn electrically-powered component device of a video capsule endoscopy system designed to be swallowed by a patient for the internal visualization and examination of the gastrointestinal (GI) tract. It is a non-digestible capsule containing a video camera intended to pass through the GI tract after being swallowed, or endoscopically introduced. It is available in various dedicated types to collect and transmit video images of GI tract sections (e.g., oesophagus, small bowel and colon) to the system operator via wireless signals from an external sensor array for examination and data recording; 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
5
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
18809260260587MiroCam Capsule Endoscope SystemMC1600-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
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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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
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10884521845831PillCam GeniusGiven Imaging, Inc.NEZ2024-11-14
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10884521836181PillCamGiven Imaging, Inc.NEZ2023-10-05
04953170214288RECORDER UNIT HARNESSOLYMPUS MEDICAL SYSTEMS CORP.NEZ2023-06-21
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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
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06921010800524 NaviCam Small Bowel Capsule Endoscopy SystemANKON Technologies Co.,Ltd.NEZ2022-12-27