FDA.reportPublic FDA data

PENTAX Medical

Primary DI
04580826928413
Brand
PENTAX Medical
Company
PENTAX MEDICAL CORPORATION
Model
OE-B14
Device description
PENTAX Medical Gas/Water Feeding Valve OE-B14
Published
2026-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
OCXEndoscopic Irrigation/Suction System
ODCEndoscope Channel Accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCXEndoscopic Irrigation/Suction SystemGastroenterology, Urology2
ODCEndoscope Channel AccessoryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232249000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232249000PENTAX Medical Gas/Water Feeding Valve OE-B14Pentax of America, Inc.2023-12-01ODC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04580826928413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04580826928413045808269284134580826928413

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope air/water valve, reusableA device intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases [i.e., air, carbon dioxide (CO2)] and/or water whilst preventing backflow. It is in the form of an attachable valve with one or more settings such as closed, insufflation (allowing air/gas in), and irrigation/rinse (allowing water in). This is a reusable device intended to be reprocessed prior to use.

Sterilization Methods#

Method table
Method
High-level Disinfectant
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
691559848
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04580826920035PENTAX MedicalEG29-i20c2026-08-25
04580826920066PENTAX MedicalEG27-i20c2026-08-25
04580826920141PENTAX MedicalEC38-i20cL2026-08-25
04580826920271PENTAX MedicalEC34-i20cL2026-08-25
04580826920295PENTAX MedicalEC38-i20cWL2026-08-25
04580826920325PENTAX MedicalEG29-i10c2026-08-25
04580826920394PENTAX MedicalEC38-i10cL2026-08-25
04580826920462PENTAX MedicalEC34-i10cL2026-08-25
04580826920653PENTAX MedicalEE17-J102026-08-25
04580826920660PENTAX MedicalEG17-J102026-08-25
04580826920684PENTAX MedicalEB19-J10U2026-08-25
04580826920721PENTAX MedicalEG38-J10UT2026-08-25
04580826920769PENTAX MedicalEG36-J10UR2026-08-25
04580826920806PENTAX MedicalEG34-J10U2026-08-25
04580826920899PENTAX MedicalEB19-J102026-08-25
04580826920929PENTAX MedicalEB15-J102026-08-25
04580826920950PENTAX MedicalEB11-J102026-08-25
04580826921001PENTAX MedicalVNL11-J102026-08-25
04580826921056PENTAX MedicalVNL11-J102026-08-25
04580826921063PENTAX MedicalVNL8-J102026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450457535C2 CryoBalloon™Merit Medical Systems, Inc.OCX2026-08-17
B382SD20260Surgical DirectSurgical Direct, Inc.OCX2026-08-03
06973141950845EndocleanChangzhou Endoclean Medical Device Co.,LtdODC2026-07-16
00850050934196EndoSound® Biopsy Port Adapter 5054Endosound, Inc.ODC2026-06-01
00850050934202EndoSound® Biopsy Port Adapter (5 pack) 5064Endosound, Inc.ODC2026-06-01
08809327356133ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356140ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356157ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356164ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356171ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356188ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356195ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
M84921890CleanCapture Aspiration CatheterHOBBS MEDICAL, INC.OCX2026-01-14
04953170465277AUXILIARY WATER TUBEOLYMPUS MEDICAL SYSTEMS CORP.OCX2025-12-05
M710TCW51000Bayou™ troCarWash System Disposable KitBIOTEX, INC.OCX2025-10-10
14953170458429SINGLE USE BIOPSY VALVEOLYMPUS MEDICAL SYSTEMS CORP.OCX2025-09-30
008500258607104-Piece Valve KitMicro-tech UsaODC2025-03-04
008500258608713-Piece Valve KitMicro-tech UsaODC2025-03-04
008500258605055-Piece Valve KitMicro-tech UsaODC2025-03-03
M78312011110Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.OCX2025-01-10
M78312011110Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.ODC2025-01-10
06973786290337Disposable Endoscope Valves KitShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)ODC2024-10-25
06973786290344Disposable Endoscope Valves KitShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)ODC2024-10-25
06973786290368Disposable Endoscope Valves KitShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)ODC2024-10-25
06973786290375Disposable Endoscope Valves KitShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)ODC2024-10-25
06973786290399Disposable Endoscope Valves KitShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)ODC2024-10-25
06973786290405Disposable Endoscope Valves KitShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)ODC2024-10-25
08057502310108Endorail SetENDOSTART SRLODC2024-10-16
00724995197681DEFENDOUS EndoscopyODC2024-07-15
40677964031517ENDOGATORMEDIVATORS INC.OCX2024-05-29