FDA.reportPublic FDA data

PENTAX

Primary DI
04961333228584
Brand
PENTAX
Company
HOYA CORPORATION
Model
FG-29V
Device description
GASTRO FIBERSCOPE FG-29V
Published
2017-04-07
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
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
K850020000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K850020000PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23Pentax Precision Instrument Corp.1985-07-09FDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333166497Direct MarkingGS10
04961333228584PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333166497049613331664974961333166497
04961333228584049613332285844961333228584

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

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
04961333227747PENTAXBS-LC12017-04-07
04961333228362PENTAXEG-3670URK2017-04-07
04961333228409PENTAXEG-3870UTK2017-04-07
04961333233793PENTAXEG-3270UK2018-08-10
04961333254316PENTAXEC-2990Li2024-07-26
04961333254323PENTAXEC34-i10L2024-07-26
04961333254330PENTAXEC-3890TLK2024-07-26
04961333254347PENTAXEC38-i10L2024-07-26
04961333254354PENTAXEC-3890Li2024-07-26
04961333254385PENTAXEG-2490K2024-07-26
04961333254392PENTAXEG27-i102024-07-26
04961333254408PENTAXEG-2990i2024-07-26
04961333254422PENTAXEG29-i102024-07-26
04961333254439PENTAXEG-3890TK2024-07-26
04961333255238VIVIDEOCP-10002025-12-19
04961333255306VIVIDEOVNL9-CP2025-12-19
04961333255191VIVIDEOCP-10002025-12-19
04961333255245VIVIDEOVNL9-CP2025-12-19
04961333254620PENTAX MedicalOE-B172024-12-13
04961333077731PENTAXOF-B1612023-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664925645NAHangzhou AGS MedTech Co., Ltd.FDS2026-06-18
06959664925676NAHangzhou AGS MedTech Co., Ltd.FDS2026-06-18
06959664925584NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664925614NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664925959NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664925980NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926017NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926048NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926314NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926345NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926376NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926406NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926673NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926703NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926734NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926765NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664927038NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664927069NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664927090NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664927120NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664927403NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664927434NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664927465NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664927496NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664928943NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664928974NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664929001NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664929032NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664929070NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664929100NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15