FDA.reportPublic FDA data

ULTRASOUND GASTROSCOPE

Primary DI
04961333232550
Brand
ULTRASOUND GASTROSCOPE
Company
PENTAX OF AMERICA, INC.
Model
EG-3670URK
Device description
RADIAL ULTRASOUND VIDEO GASTROSCOPE 2.4C (REFURBISHED)
Published
2017-04-06
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
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
K130206000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130206000PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUSPentax of America, Inc.2013-03-20ODG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333232550PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333232550049613332325504961333232550

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

Regulatory Flags#

DUNS number
083211284
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854924006255C2 CryoBalloon Ablation System FG-10252025-04-04
00854924006293C2 CryoBalloon Ablation SystemFG-10292025-04-04
04961333255313C2 CryoBalloonFG-10552024-09-12
04961333255320C2 CryoBalloonFG-10562024-09-12
04961333248445C2 CryoBalloon NitroclipFG-10502020-08-07
00854924006408C2 CryoBalloon EndoGripFG-10402020-07-29
04961333232567ULTRASOUND GASTROSCOPEEG-3870UTK2017-04-06
04961333233953ULTRASOUND GASTROSCOPEEG-3270UK2017-06-26
04961333231942VIDEO PROCESSOREPK-I5010-US2018-04-16
04961333232598VIDEO PROCESSOREPK-I50102017-04-06
04961333232604VIDEO PROCESSOREPK-I70102017-04-06
04961333242207N/A92026/102018-03-08
04961333242214N/A92026/252018-03-08
04961333242221N/A92026/32018-03-08
04961333242238N/A92026/502018-03-08
04961333242276N/A92052/202018-03-08
04961333242283N/A92052/62018-03-08
04961333242306N/A92092/122018-03-08
04961333242313N/A92092/252018-03-08
04961333242320N/A92092/62018-03-08

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Primary DI, Brand, Company table
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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
06932503534727Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
06932503534734Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
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06932503534819Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
06932503534826Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
06932503534864Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
06932503534888Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
16932503534700Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
16932503534724Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
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04953170467271PROBE DRIVING UNITOLYMPUS MEDICAL SYSTEMS CORP.ODG2025-04-16
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