FDA.reportPublic FDA data

FUJIFILM

Primary DI
04547410529128
Brand
FUJIFILM
Company
FUJIFILM CORPORATION
Model
EG-S100XT
Device description
This product is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
Published
2026-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FDSGastroscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDSGastroscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250550000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250550000FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFujifilm Corporation2026-02-17FDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14547410529125PackageGS11In Commercial Distribution
04547410529128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1454741052912514547410529125
04547410529128045474105291284547410529128

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video gastroscope, single-useAn endoscope with a flexible inserted portion intended for the visual examination and/or treatment of the oesophagus and/or stomach. It is inserted through the mouth and images are transmitted by a video system with an image sensor chip at the distal end of the endoscope and images displayed on a monitor; it may also be used to obtain biopsies or perform other procedures. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Special Storage Condition, Specify00no dew condensation.
Special Storage Condition, Specify00Stored in a packaging box.
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
713565195
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04547410480269FUJIFILMVS-10002026-05-22
04573596200865APERTO LucentMR-JCR-82Joint coil (M) MR-JCR-82 for APERTO Lucent/APEROT 2026-05-22
04573596200889APERTO LucentMR-JC-81Joint coil (S) MRJC-81 for APERTO Lucent/APERTO Et2026-05-22
04573596200896APERTO LucentMR-JCR-83Joint coil (L) MR-JCR-83 for APERTO Lucent/APEROT 2026-05-22
04573596200902APERTO LucentMR-CSC-81C-Spine coil MR-SCS-81 for APERTO Lucent/APERTO Et2026-05-22
04573596200940APERTO LucentMR-QWC-81Wrist coil MR-QWC-81 for APERTO Lucent/Aperto Eter2026-05-22
04573596200964APERTO LucentMR-MSC-81Shoulder coil MR-MSC-81 for APERTO Lucent/APERTO E2026-05-22
04573596200971APERTO LucentMR-QRC-81Head coil (L) MR-QRC-81 for APERTO Lucent/APERTO E2026-05-22
04573596201480APERTO LucentMR-QHC-81RQD Head coil R MR-QHC-81R for APERTO Lucent2026-05-22
04573596201497APERTO LucentMR-QKC-83RQD Knee coil R MR-QKC-83R for APERTO Lucent2026-05-22
04573596201503APERTO LucentMR-IBC-83Open body coil MR-IBC-83 for APERTO Lucent/APERTO 2026-05-22
04573596202210APERTO LucentMR-QFC-82NFlexible Body coil N(M) MR-QFC-82N for APERTO Luce2026-05-22
04573596202227APERTO LucentMR-QFC-83NFlexible Body coil N(L) MR-QFC-83N for APERTO Luce2026-05-22
04547410571134FDR AQRODR-XD 1000 MBL ES US E2026-03-20
14547410566250FUJIFILMDH-084STR2026-02-27
14547410566298FUJIFILMDH-094STR2026-02-27
14547410566335FUJIFILMDH-104STR2026-02-27
14547410566373FUJIFILMDH-114STR2026-02-27
14547410566410FUJIFILMDH-124STR2026-02-27
14547410566458FUJIFILMDH-134STR2026-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14547410566250FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
14547410566298FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
14547410566335FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
14547410566373FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
14547410566410FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
14547410566458FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
00850458007195GripTract-GI Endoscopic Tissue ManipulatorACTUATED MEDICAL, INC.FDS2025-12-23
14547410477150FUJIFILMFUJIFILM CORPORATIONFDS2025-05-31
04953170423628GASTROINTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FDS2025-05-26
14953170454353DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDS2025-05-13
14953170454278DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDS2025-05-12
14953170454285DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDS2025-05-12
14953170454292DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDS2025-05-12
14953170454308DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDS2025-05-12
14953170454322DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDS2025-05-12
14953170454346DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDS2025-05-12
04961333129492PENTAXHOYA CORPORATIONFDS2025-04-04
04961333211692PENTAXHOYA CORPORATIONFDS2025-04-04
04961333251070PENTAXHOYA CORPORATIONFDS2025-04-04
14547410532873FUJIFILMFUJIFILM CORPORATIONFDS2024-12-20
04961333356393PENTAX MedicalHOYA CORPORATIONFDS2024-12-13
04961333356416PENTAX MedicalHOYA CORPORATIONFDS2024-12-13
04953170452475EVIS EXERA III GASTROINTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FDS2024-10-04
14547410500643FUJIFILMFUJIFILM CORPORATIONFDS2024-09-20
04547410517330FUJIFILMFUJIFILM CORPORATIONFDS2024-09-20
14547410528265FUJIFILMFUJIFILM CORPORATIONFDS2024-09-20
00850031897076Single-Use Gastroscope 3.5/2.0 85cmEvoendo, Inc.FDS2024-08-30
00850031897083Single-Use Gastroscope 3.5/2.0 85cm 5-packEvoendo, Inc.FDS2024-08-30
00850031897090Single-Use Gastroscope 3.5/2.0 85cm DEMOEvoendo, Inc.FDS2024-08-30
04961333254828PENTAXHOYA CORPORATIONFDS2024-07-26