FDA.reportPublic FDA data

PENTAX Medical

Primary DI
04961333248933
Brand
PENTAX Medical
Company
HOYA CORPORATION
Model
EG36-J10UR
Device description
PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR (Made in Malaysia)
Published
2021-03-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
ODGEndoscopic Ultrasound System, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
ODGEndoscopic Ultrasound System, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200090000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200090000PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type)Pentax of America, Inc.2020-07-23ODG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333248902Direct MarkingGS10
04961333248933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333248902049613332489024961333248902
04961333248933049613332489334961333248933

GMDN Terms#

Term, Definition table
TermDefinition
Flexible ultrasound gastroduodenoscopeAn endoscope with a flexible inserted portion, combined with an ultrasound probe, intended for the visual examination and treatment of the upper gastrointestinal (GI) tract [oesophagus, stomach, and duodenum (the first part of the small intestine), including the pancreas and the bile duct]. It is inserted into the body through the mouth during gastroduodenoscopy. Anatomical images are transmitted to the user through a fibreoptic bundle or a video system and the ultrasound probe. The probe may be built-in, or inserted through a dedicated lumen. This device is commonly used to examine structures of the stomach, duodenum, pancreas, and bile duct. 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
00198953121382VolusonGE Ultrasound Korea Ltd.ITX2026-05-28
08800290027266PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800289975974R30 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289976025R20 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289979224EA2-11ARnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289979262CA1-7SnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027297PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027334LA2-9SnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08056304455826MyLabC25ESAOTE SPAITX2025-12-10
08056304455833MyLabC30ESAOTE SPAITX2025-12-10
08800289979132cV4 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2025-09-03
08800289981883cV5 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2025-09-03
08056304455017MyLabA50ESAOTE SPAITX2025-07-07
08056304455215MyLabE85ESAOTE SPAITX2025-07-07
08056304455307MyLabA70ESAOTE SPAITX2025-07-07
08056304455437MyLabA50ESAOTE SPAITX2025-07-07
08056304455451MyLabA70ESAOTE SPAITX2025-07-07
08056304455635MyLabE80ESAOTE SPAITX2025-07-07
08056304455642MyLabE85ESAOTE SPAITX2025-07-07
08800289970351cV8 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2025-02-27
08056304455628MyLabE80ESAOTE SPAITX2024-03-29
08056304454980MyLabX90ESAOTE SPAITX2023-12-14
08056304454676MyLabX9ESAOTE SPAITX2023-06-13
08800013544001X-CUBE 50Alpinion Medical Systems Co., Ltd.ITX2022-11-01
08800013545008X-CUBE 60Alpinion Medical Systems Co., Ltd.ITX2022-11-01
08800013511171C1-6CAlpinion Medical Systems Co., Ltd.ITX2022-07-15
08800013511164C1-7GTAlpinion Medical Systems Co., Ltd.ITX2022-02-05
08714729982852MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONITX2021-11-29
08714729982869MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONITX2021-11-29
08714729982876MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONITX2021-11-29