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PENTAX Medical Gas/Water Feeding Valve OE-B14

by PENTAX Medical Corporation

Ref 6217001A085SModel See UDI-DI information for model names

Active Active in United States. Withdrawn in European Union. Also listed in GUDID (US).

CE MDR, withdrawn 510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K232249↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04961333252121 UDI-DI Date13 Dec 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK232249 Date1 Dec 2023IssuedStatusActive
European UnionCE/MDR EUDAMED Number4961333010514Y9 Basic UDI-DI 04961333252121UDI-DIDate26 May 2023RegisteredStatusWithdrawn No longer placed on the EU market

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Withdrawn

Specification

EUDAMED · 510(k) · GUDID

Trade Name
PENTAX Medical Gas/Water Feeding Valve OE-B14 EUDAMED
PENTAX Medical GUDID
Generic Name
Endoscope air/water valve, reusable
Model / Reference
See UDI-DI information for model names EUDAMED
6217001A085S EUDAMED
OE-B14 GUDID
Primary DI / UDI-DI
04961333252121
Basic UDI-DI
4961333010514Y9
510(k) Number
FDA Product Code
ODC, OCX
EMDN Code
G0380 Digestive endoscopy devices - accessories
GMDN Term
Endoscope air/water valve, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1500
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
See UDI-DI information for model names
6217001A085S
GUDID
OE-B14
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
JP-MF-000005227
Authorised representative
PENTAX Europe GmbH DE-AR-000000006

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Category: Gastro-urological guidewire, single-use

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Properties

  • Reusable
  • CMR Substance
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No