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PENTAX Medical OF-B115

by Pentax Medical Company

Ref 04580826926778Model See UDI-DI information for model names

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

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
United StatesGUDID listing GUDID Number04580826926778 UDI-DI Date25 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number458082692010509LK Basic UDI-DI 04580826926778UDI-DIDate5 Aug 2026RegisteredStatusActive

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-2713-2017 FDA Class II initiated 17 Jan 2017

    Pentax initiated a field correction/safety alert for two (2) models of the Video Duodenoscope to determine how soiling may have occurred on the surface of the suction cylinder and under the distal cap during testing.

    • Terminated Z-2277-2016 FDA Class II initiated 6 Apr 2016

    Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Channel Cleaning Adapter OF-B115 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
04580826926778 EUDAMED
OF-B115 GUDID
Primary DI / UDI-DI
04580826926778
Basic UDI-DI
458082692010509LK
510(k) Number
FDA Product Code
FDT
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
04580826926778
GUDID
OF-B115
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Cleared under the same submission (K963056)

Other devices from Pentax Medical Company

See all devices from Pentax Medical Company →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: 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