FDA.reportPublic FDA data

CapsoAccess

Primary DI
00867770000230
Brand
CapsoAccess
Company
CAPSOVISION, INC.
Model
3
Catalog number
2668
Device description
Capsule Data Access System
Published
2018-07-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K161773000
K183192000
K192662000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161773000CapsoCam Plus (SV-3) Capsule Endoscope SystemCapsoVision, Inc.2016-10-21NEZ
K183192000CapsoCam Plus (SV-3)CapsoVision, Inc.2019-04-19NEZ
K192662000CapsoCam Plus (SV-3) Capsule Endoscopy SystemCapsoVision, Inc.2020-02-14NEZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08677700002034PreviousGS10
00867770000230PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
08677700002034086777000020348677700002034
00867770000230008677700002308677700002300867770000230

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure19 KiloPascal101 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure19 KiloPascal101 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
408.624.1488azimun.jamal@capsovision.com
408-624-1488info@capsovision.com

Regulatory Flags#

DUNS number
789635740
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00867770000278CE Deliver DLV2026-01-08
00867770000285CE Deliver DLV2026-01-08
00867770000261CapsoCam PlusSV-3KIT27952020-12-11
00867770000254CapsoRetrieveCVR112092020-09-28
00867770000223CapsoCloud2CLD2020-03-02
00867770000209CapsoCam PlusSV-327952018-07-17
00867770000247CapsoRetrieveCVR112192018-07-17
00867770000216CapsoView327592018-07-17

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