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Water Jet Channel Cleaning Adapter Oe-C20

by PENTAX Medical Corporation 2 variants

Ref 6217001Z917SModel See UDI-DI information for model names

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

FDA recalls

None ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4961333010509YG Basic UDI-DI 04961333146253UDI-DIDate12 Jul 2022RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number04961333146253 UDI-DI Date7 Apr 2017ListedStatusListed GUDID: in commercial distribution

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

2 recalls · FDA

    • Terminated Z-0318-2017 FDA Class II initiated 15 Aug 2016

    PENTAX Medical is initiating this field action to provide customers that have purchased the affected endoscopes with the most recent Operation and Reprocessing IFUs.

    • Terminated Z-2071-2016 FDA Class II initiated 6 Apr 2016

    Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Withdrawn
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Water Jet Channel Cleaning Adapter Oe-C20 EUDAMED
Pentax GUDID
Generic Name
Endoscope leak tester tubing
Device Name
Channel Cleaning Adapter
Model / Reference
See UDI-DI information for model names EUDAMED
6217001Z917S EUDAMED
OE-C20 GUDID
Primary DI / UDI-DI
04961333146253
Basic UDI-DI
4961333010509YG
FDA Product Code
FDS
EMDN Code
V0799 Products for cleaning medical devices not included in other classes - other
GMDN Term
Endoscope leak tester tubing
Device Class
Class I 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
6217001Z917S
GUDID
OE-C20
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

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

Other devices from PENTAX Medical Corporation

See all devices from PENTAX Medical Corporation →

Properties

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

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: 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