# K962897: EG-3400, Video Gastroscope

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Precision Instrument Corp.
- Decided: Oct 4, 1996 after 71 days
- Product code: FDS (Gastroscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K822846 (1982). 5 ancestors in all.
No later device cites it as a predicate yet.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K850020: Pentax Pne- Ultra-Slim Upper G.I. Fiberscope FG-23, Pentax Precision Instrument Corp. (1985) Summary page 1.
- K951574: EC-3800L, Video Colonoscope, Pentax Precision Instrument Corp. (1996) Summary page 1.
- K934918: Epm-3300 Video Processor, Pentax Precision Instrument Corp. (1994) Summary page 1.

## Recalls of this device
- Apr 6, 2016 · Class II · 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.

## Indications for use
The EG-3400, Video Gastroscope, is intended to provide optical visualization (via a video monitor) of, and therapeutic access to, the Upper Gastrointestinal Tract. The Upper Gastrointestinal Tract includes, but is not limited to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Small Bowel. The instrument is introduced per orally when indications consistent with the requirement for procedure(s) are observed in Adult and Pediatric patient populations.

Source page: https://510kreport.com/device/K962897
Methodology: https://510kreport.com/methodology