FDA.reportPublic FDA data

GASTROINTESTINAL FIBERSCOPE

Primary DI
04953170307355
Brand
GASTROINTESTINAL FIBERSCOPE
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
OLYMPUS GIF TYPE E3
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FETEndoscopic video imaging system/component, gastroenterology-urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FETEndoscopic Video Imaging System/Component, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K954451000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K954451000EVIS 140 SYSTEMOlympus America, Inc.1996-03-29FET

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170307355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170307355049531703073554953170307355

GMDN Terms#

Term, Definition table
TermDefinition
Flexible fibreoptic gastroscopeAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the oesophagus and the stomach. It is inserted into the body through the mouth during gastroscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used in the evaluation or treatment of unusual abdominal pain, bleeding, cancer, chronic heartburn, polyps, gastritis, ulcers, or hiatal hernia. Physicians may also use the device to obtain biopsies or perform other procedures. This is a reusable device.

Sterilization Methods#

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags#

DUNS number
711789789
Device count
1
DM exempt
true
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
04953170025693P CORDMAJ-348125002016-09-21
04953170048548A CORDMH-9692016-09-21
04953170062872A CORDMAJ-8602016-09-21
04953170373763ENDOCAPSULE SOFTWARE 10MAJ-2188N54003402016-09-21
04953170373800ENDOCAPSULE SOFTWARE 10 LIGHTMAJ-2189N54004402016-09-21
04953170373848ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGEMAJ-2190N54005402016-09-21
04953170360817ENDOCAPSULE SOFTWARE 10 SOFT SERVER-CLIENTMAJ-2038N53688402023-06-21
04953170360824ENDOCAPSULE SOFTWARE 10 SOFTWARE CLIENTMAJ-2039N53689402023-06-21
04953170410178EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPEOLYMPUS GF-UE190N60031402025-11-19
04953170411939Single Use Biopsy Forceps FB-456DFB-456DN60083302020-09-29
04953170424724Infrared imaging unitMAJ-2304N57695452021-05-31
04953170428142VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IRN54270452021-03-03
04953170054358BrushMH-36241168002016-09-21
04953170058783BALLOON3MAJ-2332017-10-12
04953170058882BALLOON3MAJ-2492017-10-12
04953170142628SonoSurg TransducerSonoSurg-T2H-C2017-10-06
04953170208485Cleaning brushMAJ-1534N23010002016-09-21
04953170234859SonoSurg Straight Scissors,Pistol Grip,5mm x 34cmT37712017-10-06
04953170234880SonoSurg Curved Scissors,Pistol Grip,5mm x 34cmT37752017-10-06
04953170234941SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 34cmT39002017-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826921438PENTAX MedicalPENTAX MEDICAL CORPORATIONFET2026-08-25
04580826927713PENTAX MedicalPENTAX MEDICAL CORPORATIONFET2026-08-25
04580826930935INSPIRAPENTAX MEDICAL CORPORATIONFET2026-08-25
04580826930959INSPIRAPENTAX MEDICAL CORPORATIONFET2026-08-25
17290016992158SOLO SCOPE Disposable ColonoscopeG.I. VIEW LTDFET2026-08-25
17290016992172SOLO SCOPE Video ControllerG.I. VIEW LTDFET2026-08-25
04953170421594HD CAMERA HEADOLYMPUS MEDICAL SYSTEMS CORP.FET2026-07-22
04547410480269FUJIFILMFUJIFILM CORPORATIONFET2026-05-22
00840432200063CystoView™Verathon Medical (Canada) ULCFET2026-05-15
00840432200117CystoView™Verathon Medical (Canada) ULCFET2026-05-15
00840432200308CystoView™Verathon Medical (Canada) ULCFET2026-05-15
00840432200315CystoView™Verathon Medical (Canada) ULCFET2026-05-15
00840432200322CystoView™Verathon Medical (Canada) ULCFET2026-05-15
04049047788553GimmiGimmi GmbHFET2026-03-04
04049047788577GimmiGimmi GmbHFET2026-03-04
04049047788584GimmiGimmi GmbHFET2026-03-04
06971176282399EviewZhuhai Pusen Medical Technology Co, LtdFET2026-01-22
06972520300677Endoscopic Video Image ProcessorGuangzhou Red Pine Medical Instrument Co., Ltd.FET2025-12-31
05391533810088ProVee Video Processing UnitPROVERUM LIMITEDFET2025-12-02
05391533810095ProVee Video Processing UnitPROVERUM LIMITEDFET2025-12-02
04953170445538OTV-S700 UPGRADE PACK IROLYMPUS MEDICAL SYSTEMS CORP.FET2025-11-21
04048551418123n.a.Karl Storz GmbH & Co. KGFET2025-08-11
04961333255801INSPIRAHOYA CORPORATIONFET2025-06-20
04961333255825INSPIRAHOYA CORPORATIONFET2025-06-20
04250480104200NASCHÖLLY FIBEROPTIC GmbHFET2025-06-11
04250480104262N/ASCHÖLLY FIBEROPTIC GmbHFET2025-06-11
04547410513790FUJIFILMFUJIFILM CORPORATIONFET2025-05-31
049531704302684K Camera HeadOLYMPUS MEDICAL SYSTEMS CORP.FET2025-04-17
04953170433313VISERA ELITE III VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.FET2025-04-17
04953170433412VISERA ELITE III LED LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.FET2025-04-17