FDA.reportPublic FDA data

PENTAX Medical

Primary DI
04961333252145
Brand
PENTAX Medical
Company
HOYA CORPORATION
Model
EG29-i20c
Device description
PENTAX Medical Video Upper GI Scope EG29-i20c
Published
2023-09-20
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
FDFColonoscope And Accessories, Flexible/Rigid
FDSGastroscope And Accessories, Flexible/Rigid
PEAEndoscope, Accessories, Image Post-Processing For Color Enhancement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2
FDSGastroscope And Accessories, Flexible/RigidGastroenterology, Urology2
PEAEndoscope, Accessories, Image Post-Processing For Color EnhancementGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231249000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231249000PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cLPentax of America, Inc.2023-07-28PEA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333251858Direct MarkingGS10
04961333252145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333251858049613332518584961333251858
04961333252145049613332521454961333252145

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

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
04961333254392PENTAXEG27-i102024-07-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290016992113Aer-O-Scope Disposable ColonoscopeG.I. VIEW LTDFDF2026-05-27
00724995246723DEFENDO Air/Water/Suction and Biopsy ValveMEDIVATORS INC.FDF2026-04-06
00724995246730DEFENDO Air/Water and Suction ValvesMEDIVATORS INC.FDF2026-04-06
00724995246747DEFENDO Valve and Connector KitMEDIVATORS INC.FDF2026-04-06
00724995246754Defendo Single Use Valve KitMEDIVATORS INC.FDF2026-04-06
00724995246761Defendo Single Use Valve KitMEDIVATORS INC.FDF2026-04-06
00724995246778Defendo Single Use Valve KitMEDIVATORS INC.FDF2026-04-06
00724995246785Defendo Single Use Valve KitMEDIVATORS INC.FDF2026-04-06
00724995246792DEFENDO Valve and Connector KitMEDIVATORS INC.FDF2026-04-06
00724995246808DEFENDO Air/Water/Suction and Biopsy ValveMEDIVATORS INC.FDF2026-04-06
00724995246815DEFENDO Air/Water and Suction ValvesMEDIVATORS INC.FDF2026-04-06
04547410566253FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
04547410566253FUJIFILMFUJIFILM CORPORATIONFDF2026-02-27
04547410566291FUJIFILMFUJIFILM CORPORATIONFDF2026-02-27
04547410566291FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
04547410566338FUJIFILMFUJIFILM CORPORATIONFDF2026-02-27
04547410566338FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
04547410566376FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
04547410566376FUJIFILMFUJIFILM CORPORATIONFDF2026-02-27
04547410566413FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
04547410566413FUJIFILMFUJIFILM CORPORATIONFDF2026-02-27
04547410566451FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
04547410566451FUJIFILMFUJIFILM CORPORATIONFDF2026-02-27
04547410477245FUJIFILMFUJIFILM CORPORATIONFDF2025-06-30
04547410477276FUJIFILMFUJIFILM CORPORATIONFDF2025-06-30
04547410477306FUJIFILMFUJIFILM CORPORATIONFDF2025-06-30
04547410477153FUJIFILMFUJIFILM CORPORATIONFDS2025-05-31
04547410513790FUJIFILMFUJIFILM CORPORATIONFDS2025-05-31
04547410513790FUJIFILMFUJIFILM CORPORATIONPEA2025-05-31
00850458007157GripTract-GI Endoscopic Tissue ManipulatorACTUATED MEDICAL, INC.FDF2025-01-16