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PENTAX Medical Cylinder Cleaning Adapter OE-B16

by PENTAX Medical Corporation 2 variants

Ref 6217001A087SModel 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Withdrawn Withdrawn in European Union.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Was authorized under CE MDR, withdrawn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Withdrawn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

4 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04961333251834 UDI-DI Date20 Sep 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number4961333010509YG Basic UDI-DI 04961333251834UDI-DIDate12 Jul 2022RegisteredStatusWithdrawn 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

4 recalls · 4 ongoing · FDA

    • Ongoing Z-2329-2025 FDA Class II initiated 16 Jul 2025

    During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endoscope, the observed image can become reddish or dark. Users have observed smoke like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient and may cause thermal injury to the patient s mucous membrane.

  • 3 recalls, same reason

    • Ongoing Z-1237-2025 FDA Class II initiated 29 Jan 2025
    • Ongoing Z-1236-2025 FDA Class II initiated 29 Jan 2025
    • Ongoing Z-1238-2025 FDA Class II initiated 29 Jan 2025

    During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.

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
PENTAX Medical Cylinder Cleaning Adapter OE-B16 EUDAMED
PENTAX Medical GUDID
Generic Name
Endoscope leak tester tubing
Device Name
Channel Cleaning Adapter
Model / Reference
See UDI-DI information for model names EUDAMED
6217001A087S EUDAMED
OE-B16 GUDID
Primary DI / UDI-DI
04961333251834
Basic UDI-DI
4961333010509YG
Direct Marketing DI
04961333251834
FDA Product Code
PEA, FDS, FDF
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
6217001A087S
GUDID
OE-B16
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