FDA.reportPublic FDA data

PENTAX Medical

Primary DI
04961333251766
Brand
PENTAX Medical
Company
HOYA CORPORATION
Model
EE17-J10
Device description
PENTAX Medical Video Esophagoscope EE17-J10
Published
2023-06-21
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
EOXEsophagoscope (Flexible Or Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOXEsophagoscope (Flexible Or Rigid)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223072000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223072000PENTAX Medical Video Esophagoscope EE17-J10Pentax of America, Inc.2022-12-02EOX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333246083Direct MarkingGS10
04961333251766PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333246083049613332460834961333246083
04961333251766049613332517664961333251766

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video gastroscope, reusableAn 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 reusable device.

Sterilization Methods#

Method table
Method
"[""High-level Disinfectant"", ""Liquid Chemical""]"

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
00860008795557EsoCheck CCD Cell Collection DeviceLucid Diagnostics IncEOX2023-01-26
04048551417348n.a.Karl Storz GmbH & Co. KGEOX2020-03-02
00860002356006EsoCheck CCD Cell Collection DeviceLucid Diagnostics IncEOX2019-12-17
00874485003210UNITY 9100COGENTIX MEDICAL, INC.EOX2018-12-20
04048551178515n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
04048551178539n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
04048551178546n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
04048551190098n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
04048551190104n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
04048551190111n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
00874485002985EndoSheath TechnologyCOGENTIX MEDICAL, INC.EOX2016-09-23
00874485003005EndoSheath TechnologyCOGENTIX MEDICAL, INC.EOX2016-09-23
04048551001387n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551001493n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551001974n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047675n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047811n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047828n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047866n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047873n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047897n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047903n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047941n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047989n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047996n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551048641n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551048658n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551053591n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551068762n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551068786n.a.Karl Storz GmbH & Co. KGEOX2016-09-23