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N/A Kumof-B173K

by PENTAX of America, Inc.

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04961333243389 UDI-DI Date14 Mar 2018ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · FDA

    • 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.

    • Terminated Z-0819-2012 FDA Unclassified (pre-2012) initiated 30 Sep 2011 on shared 510(k) K961564

    The wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the bronchoscope.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Endoscope working-channel seal
Model / Reference
KUMOF-B173K
Primary DI / UDI-DI
04961333243389
FDA Product Code
FDS
GMDN Term
Endoscope working-channel seal
Device Class
Class II
Regulation Number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Endoscope working-channel seal

Cleared under the same submission (K961564)

Other devices from PENTAX of America, Inc.

See all devices from PENTAX of America, Inc. →

Properties

  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number

Other properties (11)

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