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PENTAX Medical OF-B121

by Pentax Medical Company

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 closed

Documents

None

No authorization documents

Trust

Unverified

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

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04580826926792 UDI-DI Date25 Aug 2026ListedStatusListed GUDID: in commercial distribution

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

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
PENTAX Medical
Generic Name
Endoscope air/water valve, reusable
Model / Reference
OF-B121
Primary DI / UDI-DI
04580826926792
510(k) Number
FDA Product Code
FDT
GMDN Term
Endoscope air/water valve, reusable
Device Class
Class II
Regulation Number
876.1500
GUDID distribution status
In Commercial Distribution

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 (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No