FDA.reportPublic FDA data

PillCam

Primary DI
07290101362364
Brand
PillCam
Company
Covidien LP
Model
FGS-0419
Device description
SB 2-EX capsule, 5-pack
Published
2017-01-31
Public version status
Update
Distribution status
Not 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
K101250000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101250000GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESGiven Imaging , Ltd.2011-03-07NEZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290101362364PrimaryGS10
10884521726109Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290101362364072901013623647290101362364
1088452172610910884521726109

GMDN Terms#

Term, Definition table
TermDefinition
Video capsule endoscopy systemAn assembly of electronic devices designed for the internal visualization and examination of sections of the gastrointestinal (GI) tract using a non-digestible video capsule after it has been swallowed by a patient. The system typically consists of an operator workstation, various types of video capsules, an external sensor device that receives the wireless signals from the capsule, and a data recorder. As the capsule passes through the GI tract, video images of it sections (e.g., oesophagus, small bowel and colon) are relayed to the operator for examination and data recording; the capsule is egested from the gut.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature20 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00;
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
058614483
Device count
5
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521072602V-LocVLOCN204L2015-09-02
20884521126852Sofsilk1700022016-09-24
10884521091986NellcorSC-A-I2026-05-25
10884521758803Vascufil8886470311V-22020-07-19
10884521816312McGRATH MAC350-005-0002021-10-21
10884521816329McGRATH MAC350-013-0002021-08-30
10884521816336McGRATH MAC350-017-0002021-10-18
10884521816343McGRATH MAC350-072-0002022-06-13
10884521824317McGRATH MAC350-005-0002022-09-25
10884521824324McGRATH MAC350-013-0002021-10-30
10884521824331McGRATH MAC350-017-0002021-08-26
10884521824348McGRATH MAC350-072-0002023-06-19
10884521850118McGRATH MAC350-005-0002025-04-27
10884521850125McGRATH MAC350-013-0002025-04-27
10884521850132McGRATH MAC350-017-0002025-04-27
10884521850149McGRATH MAC350-072-0002025-04-27
15060272980310McGRATH MAC350-005-0002021-08-02
15060272980327McGRATH MAC350-013-0002022-01-17
15060272980334McGRATH MAC350-072-0002021-04-18
15060272980341McGRATH MAC350-017-0002021-03-27

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
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
06921010800494 NaviCam Small Bowel Capsule Endoscopy SystemANKON Technologies Co.,Ltd.NEZ2022-12-27
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