FDA.reportPublic FDA data

PillCam Genius

Primary DI
10884521845848
Brand
PillCam Genius
Company
Given Imaging, Inc.
Model
FGS-0689
Device description
SB Capsule Endoscopy Kit
Published
2024-11-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

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
K240276000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240276000PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader SoftwareGiven Imaging Ltd. (D.B.A. Medtronic)2024-05-10NEZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521845848PrimaryGS10
20884521845845Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452184584810884521845848
2088452184584520884521845845

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile, Keep dry
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius26 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
090073722
Device count
5
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290101365921ManoScanFGS-05712017-07-20
07290101369578ManoViewFGS-06282019-08-11
10884521855441ManoScanFGS-07152025-08-21
07290101364221PillCamRFB-03472017-02-02
04260167480954ManoScan38852016-09-24
04260167480961ManoScan38872016-09-24
04260167482446ManoScan38902016-09-24
04260167482460ManoScan21952016-09-24
04260167482477ManoScan21922016-09-24
04260167482484ManoScan12862016-09-24
07290101365686PillCamRFB-01542016-09-24
10884521853317ManoScanFGS-80382025-01-25
10884521846975PillCam GeniusFGS-08062024-11-29
20884521845845PillCam GeniusFGS-06892024-11-29
10884521845831PillCam GeniusFGS-06882024-11-14
10884521845916PillCamFGS-08022024-11-14
10884521845923PillCamFGS-08032024-11-14
10884521836181PillCamFGS-07072023-10-05
07290101364474PillcamRFB-03552017-02-02
04260167483740Versaflex9000032018-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810164590114NaviCam Data RecorderANX ROBOTICA CORPNEZ2026-02-16
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
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
06921010800531 NaviCam Small Bowel Capsule Endoscopy SystemANKON Technologies Co.,Ltd.NEZ2022-12-27