# K031789: EG-3830UT, Video Ultrasound Gastroscope

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Precision Instrument Corp.
- Decided: Aug 8, 2003 after 59 days
- Product code: ODG (Endoscopic Ultrasound System, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K812810 (1981). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023401: EG-3830UT, Video Ultrasound Gastroscope, Pentax Precision Instrument Corp. (2003) Summary page 4.
- K981434: Eup-OL334 Laparascopicprobe, Hitachi Medical Corp. of America (1998) Summary page 4.

## Indications for use
The EG-3830UT, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract. The Upper Gastrointestinal Tract includes but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations. Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows

Source page: https://510kreport.com/device/K031789
Methodology: https://510kreport.com/methodology