FDA.reportPublic FDA data

PENTAX

Primary DI
04961333254392
Brand
PENTAX
Company
HOYA CORPORATION
Model
EG27-i10
Device description
PENTAX VIDEO UPPER G.I.SCOPE EG27-i10
Published
2024-07-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FDSGastroscope and accessories, flexible/rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDSGastroscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131902000
K251256000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131902000PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)Pentax Medical Company2014-04-10FDS
K251256000PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)Pentax of America, Inc.2025-12-16FDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333254842Direct MarkingGS10
04961333254392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333254842049613332548424961333254842
04961333254392049613332543924961333254392

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video gastroscope, reusableAn endoscope with a flexible inserted portion intended for the visual examination and/or treatment of the oesophagus and/or stomach. It is inserted through the mouth and images are transmitted by a video system with an image sensor chip at the distal end of the endoscope and images displayed on a monitor; it may also be used to obtain biopsies or perform other procedures. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Liquid Chemical"", ""High-level Disinfectant""]"

Regulatory Flags#

DUNS number
691519705
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04961333227747PENTAXBS-LC12017-04-07
04961333228362PENTAXEG-3670URK2017-04-07
04961333228409PENTAXEG-3870UTK2017-04-07
04961333233793PENTAXEG-3270UK2018-08-10
04961333254316PENTAXEC-2990Li2024-07-26
04961333254323PENTAXEC34-i10L2024-07-26
04961333254330PENTAXEC-3890TLK2024-07-26
04961333254347PENTAXEC38-i10L2024-07-26
04961333254354PENTAXEC-3890Li2024-07-26
04961333254385PENTAXEG-2490K2024-07-26
04961333254408PENTAXEG-2990i2024-07-26
04961333254422PENTAXEG29-i102024-07-26
04961333254439PENTAXEG-3890TK2024-07-26
04961333255238VIVIDEOCP-10002025-12-19
04961333255306VIVIDEOVNL9-CP2025-12-19
04961333255191VIVIDEOCP-10002025-12-19
04961333255245VIVIDEOVNL9-CP2025-12-19
04961333254620PENTAX MedicalOE-B172024-12-13
04961333077731PENTAXOF-B1612023-07-31
04961333079551PENTAXOE-B12023-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04547410566253FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
04547410566291FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
04547410566338FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
04547410566376FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
04547410566413FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
04547410566451FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
04547410477153FUJIFILMFUJIFILM CORPORATIONFDS2025-05-31
04547410513790FUJIFILMFUJIFILM CORPORATIONFDS2025-05-31
04953170425103COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FDS2025-05-26
04953170425158COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FDS2025-05-26
04547410532876FUJIFILMFUJIFILM CORPORATIONFDS2024-12-20
04547410500646FUJIFILMFUJIFILM CORPORATIONFDS2024-09-20
04547410528268FUJIFILMFUJIFILM CORPORATIONFDS2024-09-20
00850006222322Pathfinder® CR SystemNEPTUNE MEDICAL INC.FDS2024-07-09
14961333079343PENTAXHOYA CORPORATIONFDS2023-07-31
14961333085535PENTAXHOYA CORPORATIONFDS2023-07-31
04953170414596EVIS X1 VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.FDS2023-07-04
0495317041560912G-SDI cable 1.5MOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-07-04
0495317041562312G-SDI cableOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-07-04
0495317041563012G-SDI cable 8.5MOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-07-04
049531704156473G-SDI cable 1.5MOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-07-04
04953170415654Foot holderOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-07-04
04953170415685Footswitch Conversion cableOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-07-04
04953170420191GASTROINTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-07-04
04953170424281COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-07-04
04953170424298COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-07-04
04953170453823DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-04-29
04953170453830DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-04-29
04953170453847DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-04-29
04953170453854DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-04-29