FDA.reportPublic FDA data

PENTAX Medical

Primary DI
04961333252121
Brand
PENTAX Medical
Company
HOYA CORPORATION
Model
OE-B14
Device description
PENTAX Medical Gas/Water Feeding Valve OE-B14
Published
2023-12-13
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
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
04961333252121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333252121049613332521214961333252121

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic procedure air/water valve, reusableA non-sterile 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""]"
High-level Disinfectant;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
691519705
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04961333255528PENTAX MedicalOE-B92026-08-25
04961333256181PENTAXOF-B1902026-08-25
14961333079343PENTAXOF-B1732023-07-31
14961333085535PENTAXOE-A412023-07-31
14961333232960PENTAX MedicalOE-A622023-07-31
04961333084753PENTAXOF-B802023-07-31
04961333225569PENTAX MedicalEB19-J10U2020-07-17
04961333239825VIVIDEOCP-10002024-02-07
04961333244744DEFINAEPK-30002020-07-17
04961333245888PENTAX MedicalEG34-i102020-07-17
04961333246632PENTAX MedicalED32-i102022-02-02
04961333246779PENTAXEC-3890Li2025-04-04
04961333246830PENTAXEC38-i10L2025-04-04
04961333246847PENTAXEG-2990i2025-04-04
04961333246939PENTAXEG29-i102025-04-04
04961333248056PENTAX MedicalVNL11-J102022-02-02
04961333248063PENTAX MedicalVNL8-J102022-02-02
04961333248070PENTAX MedicalVNL15-J102022-02-02
04961333248148PENTAXEC-3890Li2020-12-14
04961333248179PENTAXEG-2990i2020-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826928413PENTAX MedicalPENTAX MEDICAL CORPORATIONOCX2026-08-25
04580826928413PENTAX MedicalPENTAX MEDICAL CORPORATIONODC2026-08-25
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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.ODC2025-01-10
M78312011110Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.OCX2025-01-10
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