FDA.reportPublic FDA data

EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

Primary DI
04953170452475
Brand
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
OLYMPUS GIF-1TH190
Catalog number
N4505842
Published
2024-10-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDSGastroscope And Accessories, Flexible/Rigid
NWBEndoscope, Accessories, Narrow Band Spectrum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDSGastroscope And Accessories, Flexible/RigidGastroenterology, Urology2
NWBEndoscope, Accessories, Narrow Band SpectrumGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232997000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232997000EVIS Exera III Gastrointestinal Videoscope GIF-1TH190Olympus Medical Systems Corporation2024-06-19FDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170452475PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170452475049531704524754953170452475

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video gastroduodenoscopeAn endoscope with a flexible inserted portion 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 by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope and the images showing on a monitor. It can be end-viewing (looking forward) or side-viewing (looking to one side) and is used for the cannulation of the pancreas and bile duct. 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
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
04953170158759DISPOSABLE HOT BIOPSY FORCEPSFD-210U2016-09-21
04953170158766DISPOSABLE HOT BIOPSY FORCEPSFD-230U2016-09-21
04953170354236DISPOSABLE HOT BIOPSY FORCEPSFD-210UN53565302016-09-21
04953170354243DISPOSABLE HOT BIOPSY FORCEPSFD-230UN53566302016-09-21
04953170214288RECORDER UNIT HARNESSMAJ-1475N24838302023-06-21
04953170331718Light guideOCS5-LG2016-09-21
04953170333316RECORDER HOLDERMAJ-2033N44720302016-09-21
04953170467592DISPOSABLE BIOPSY FORCEPSFB-211DN54318422026-04-09
04953170467608DISPOSABLE BIOPSY FORCEPSFB-221DN54319422026-04-09
04953170467615DISPOSABLE BIOPSY FORCEPSFB-231DN54320422026-04-09
04953170467622DISPOSABLE BIOPSY FORCEPSFB-241DN54321422026-04-09
04953170466038Single Use Electrosurgical Hemostatic ForcepsFD-410LRN10861412026-04-01
04953170466182Single Use Electrosurgical Hemostatic ForcepsFD-411URN30463402026-04-01
04953170466267Single Use Electrosurgical Hemostatic ForcepsFD-412LRN53686402026-04-01
04953170035647ELECTROSURGICAL SNARESD-5L-12016-09-21
04953170035708ELECTROSURGICAL SNARESD-5U-12016-09-21
04953170035838ELECTROSURGICAL SNARESD-6U-12016-09-21
04953170035951ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170035968ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170036033ELECTROSURGICAL SNARESD-8P-12016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04547410566253FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
04547410566291FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
04547410566338FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
04547410566376FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
04547410566413FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
04547410566451FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
04547410477153FUJIFILMFUJIFILM CORPORATIONFDS2025-05-31
04547410513790FUJIFILMFUJIFILM CORPORATIONFDS2025-05-31
04547410513790FUJIFILMFUJIFILM CORPORATIONNWB2025-05-31
04547410532876FUJIFILMFUJIFILM CORPORATIONFDS2024-12-20
04547410500646FUJIFILMFUJIFILM CORPORATIONFDS2024-09-20
04547410528268FUJIFILMFUJIFILM CORPORATIONFDS2024-09-20
00850006222322Pathfinder® CR SystemNEPTUNE MEDICAL INC.FDS2024-07-09
07613327616682SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616699SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616705SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616712SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616729SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616743SPYSTRYKER CORPORATIONNWB2024-02-27
076133276089151788STRYKER CORPORATIONNWB2023-12-11
14961333079343PENTAXHOYA CORPORATIONFDS2023-07-31
14961333085535PENTAXHOYA CORPORATIONFDS2023-07-31
04547410138511FUJIFILMFUJIFILM CORPORATIONFDS2022-10-07
04547410416176FUJIFILMFUJIFILM CORPORATIONFDS2022-09-19
04547410446142FUJIFILMFUJIFILM CORPORATIONFDS2022-09-19
04547410446128FUJIFILMFUJIFILM CORPORATIONFDS2022-09-19
00860226002536Visura TEECAD Carrier Control UnitVISURA TECHNOLOGIES, INC.FDS2022-07-26
04953170063749EYEPIECE CAPOLYMPUS MEDICAL SYSTEMS CORP.FDS2021-12-20
04953170064012LIGHTGUIDE CAPOLYMPUS MEDICAL SYSTEMS CORP.FDS2021-12-20
04953170216961EVIS EXERA II XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.NWB2021-12-17