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Pentax Eg-3890TK

by Hoya Corporation 2 variants

Pentax Eg-3890TK is a Class II device made by Hoya Corporation, cleared under FDA 510(k) K131902 on 10 Apr 2014 and listed in FDA GUDID since 26 Jul 2024 (UDI-DI 04961333254439), active as of 22 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

510(k) K131902

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04961333254439 UDI-DI Date26 Jul 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK131902 Date10 Apr 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K131902 decided 10 Apr 2014 Active
  • FDA GUDID UDI-DI 04961333254439 listed 26 Jul 2024 Listed

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.

Timeline

4 dated events

  1. Cleared FDA 510(k) K131902
  2. Recall initiated FDA recalls Z-2071-2016
  3. Recall initiated FDA recalls Z-0318-2017
  4. Listed FDA GUDID 04961333254439

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Pentax
Generic name
Flexible video gastroscope, reusable
Model / reference
EG-3890TK
Primary DI / UDI-DI
04961333254439
FDA product code
FDS
GMDN term
Flexible video gastroscope, reusable
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Flexible video gastroscope, reusable

Cleared under the same submission (K131902)

and 8 more cleared under K131902

Similar devices

Other devices filed under FDA product code FDS (Gastroscope and accessories, flexible/rigid).

Other devices from Hoya Corporation

See all devices from Hoya Corporation →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)