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PENTAX EG-290Kp

by Hoya Corporation

PENTAX EG-290Kp is a Class II device made by Hoya Corporation, cleared under FDA 510(k) K962897 on 4 Oct 1996 and listed in FDA GUDID since 7 Apr 2017 (UDI-DI 04961333224913), active as of 22 Oct 2026. One FDA recall is 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

1 closed

Documents

510(k) K962897

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 Number04961333224913 UDI-DI Date7 Apr 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK962897 Date4 Oct 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K962897 decided 4 Oct 1996 Active
  • FDA GUDID UDI-DI 04961333224913 listed 7 Apr 2017 Listed

Recalls

1 recall · 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.

Timeline

3 dated events

  1. Cleared FDA 510(k) K962897
  2. Recall initiated FDA recalls Z-2071-2016
  3. Listed FDA GUDID 04961333224913

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  • Withdrawn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-290Kp
Primary DI / UDI-DI
04961333224913
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 (K962897)

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)