Enteroscope Vsb-3430K
Enteroscope Vsb-3430K 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 04961333232925), 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 | Number04961333232925 | Date6 Apr 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK962897 | Date4 Oct 1996 | StatusActive |
Official records
- AccessGUDID record 04961333232925
- FDA 510(k) database K962897
Across registries
- FDA 510(k) K962897 decided 4 Oct 1996 Active
- FDA GUDID UDI-DI 04961333232925 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 04961333232925
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Enteroscope
- Generic name
- Flexible video enteroscope
- Model / reference
- VSB-3430K
- Primary DI / UDI-DI
- 04961333232925
- FDA product code
- FDS
- GMDN term
- Flexible video enteroscope
- 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).
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- OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P by Olympus Optical Co., Ltd.
- FOREIGN BODY HOOD by United States Endoscopy Group, Inc.
- PENTAX Medical OE-B17 by Pentax Medical Company
- PENTAX FG-34JA GASTROFIBERSCOPE by Pentax Precision Instrument Corp.
- PENTAX Medical OE-C29 by Pentax Medical Company
- DISPOSABLE EMR KIT K-008 by Olympus Medical Systems Corporation
- LF-DP GASTROINTESTINAL AND SIGMOID FIBERSCOPE, ACCESSORIES AND ANCILLARY EQUIPMENT by Olympus Optical Co., Ltd.
- VISION SYSTEM UPPER G.I. EXDOSCOPE by Vision-Sciences, Inc.