Video Gastroscope Eg-290KP
Video Gastroscope Eg-290KP is a Class II device made by PENTAX of America Inc., cleared under FDA 510(k) K962897 on 4 Oct 1996 and listed in FDA GUDID since 6 Apr 2017 (UDI-DI 04961333232499), active as of 8 Nov 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04961333232499 | Date6 Apr 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK962897 | Date4 Oct 1996 | StatusActive |
Official records
- AccessGUDID record 04961333232499
- FDA 510(k) database K962897
Across registries
- FDA 510(k) K962897 decided 4 Oct 1996 Active
- FDA GUDID UDI-DI 04961333232499 listed 6 Apr 2017 Listed
Recalls
-
- Terminated Z-2071-2016
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
- Cleared FDA 510(k) K962897
- Recall initiated FDA recalls Z-2071-2016
- Listed FDA GUDID 04961333232499
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Video Gastroscope
- Generic name
- Flexible video gastroscope, reusable
- Model / reference
- EG-290KP
- Primary DI / UDI-DI
- 04961333232499
- FDA product code
- FDS
- GMDN term
- Flexible video gastroscope, reusable
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code FDS (Gastroscope And Accessories, Flexible/Rigid).
- Fuse Gastroscopy System by Endochoice, Inc.
- DISPOSABLE DISTAL ATTACHMENT D-201-14304 by Olympus Medical Systems Corporation
- CLEARPATH UGI by Easyglide, Ltd.
- FUJIFILM Distal Cap Models 33-40 by FUJIFILM CORPORATION
- Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) by Iq Endoscopes Limited
- TWO CHANNEL GASTROFIBERSCOPE FG-36T by Pentax Precision Instrument Corp.
- EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes by Fujifilm Medical System U.S.A., Inc.
- DISPOSABLE DISTAL ATTACHMENT D-201-11304 by Olympus Medical Systems Corporation
- PENTAX Medical OE-C29 by HOYA CORPORATION
- Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 by Fujifilm Medical System U.S.A., Inc.