FDA.reportPublic FDA data

PENTAX

Primary DI
04961333228409
Brand
PENTAX
Company
HOYA CORPORATION
Model
EG-3870UTK
Device description
ULTRASOUND UPPER G.I.VIDEOSCOPE EG-3870UTK
Published
2017-04-07
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
ODGEndoscopic ultrasound system, gastroenterology-urology

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130247000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130247000PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUSPentax of America, Inc.2013-03-20ODG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333135899Direct MarkingGS10
04961333228409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333135899049613331358994961333135899
04961333228409049613332284094961333228409

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"", ""Ethylene Oxide""]"
High-level Disinfectant;Ethylene Oxide

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
04961333255528PENTAX MedicalOE-B92026-08-25
04961333256181PENTAXOF-B1902026-08-25
14961333079343PENTAXOF-B1732023-07-31
14961333085535PENTAXOE-A412023-07-31
14961333232960PENTAX MedicalOE-A622023-07-31
04961333084753PENTAXOF-B802023-07-31
04961333225569PENTAX MedicalEB19-J10U2020-07-17
04961333239825VIVIDEOCP-10002024-02-07
04961333244744DEFINAEPK-30002020-07-17
04961333245888PENTAX MedicalEG34-i102020-07-17
04961333246632PENTAX MedicalED32-i102022-02-02
04961333246779PENTAXEC-3890Li2025-04-04
04961333246830PENTAXEC38-i10L2025-04-04
04961333246847PENTAXEG-2990i2025-04-04
04961333246939PENTAXEG29-i102025-04-04
04961333248056PENTAX MedicalVNL11-J102022-02-02
04961333248063PENTAX MedicalVNL8-J102022-02-02
04961333248070PENTAX MedicalVNL15-J102022-02-02
04961333248148PENTAXEC-3890Li2020-12-14
04961333248179PENTAXEG-2990i2020-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826920721PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826920769PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826920806PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826926396PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826926501PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826926518PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826926532PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826926556PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826926600PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826926723PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826927010PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826927881PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826928291PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826928307PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826928444PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826928468PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826928567PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826928574PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826928628PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826928703PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826928956PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
00191506062620RIVOS™BOSTON SCIENTIFIC CORPORATIONODG2026-06-25
00850050934240EndoSound® EVS SideBeam 5103Endosound, Inc.ODG2026-06-01
00850050934257EndoSound® Coax Transducer Extension Connector (TEC)Endosound, Inc.ODG2026-06-01
00850050934264EndoSound® EVS SideBeam 5105 (4 pouches)Endosound, Inc.ODG2026-06-01
04953170467288ULTRASONIC PROBEOLYMPUS MEDICAL SYSTEMS CORP.ODG2026-01-21
04953170467318ULTRASONIC PROBEOLYMPUS MEDICAL SYSTEMS CORP.ODG2026-01-21
04953170410178EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.ODG2025-11-19
04953170467356EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180OLYMPUS MEDICAL SYSTEMS CORP.ODG2025-09-25
06932503534703Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30