# K090196: EG-3670URK

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Medical Company
- Decided: May 19, 2009 after 112 days
- Product code: ODG (Endoscopic Ultrasound System, Gastroenterology-Urology)
- 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: 5 generations back to K812810 (1981). 12 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061068: EG-3670URK, Pentax Medical Company (2006) Summary page 1.
- K063518: HI Vision 900 Diagnostic Ultrasound Scanner, Hitachi Medical Systems America, Inc. (2006)

## Most influential descendants
- K130206: Pentax EG-3670URK Ultrasound Video Gastroscope + HI Vision Preirus (2013), 1 descendant of its own
- K231813: Ultrasonic Gastrovideoscope (2024), 0 descendants of its own

## Recalls of this device
- May 23, 2017 · Class II · Z-3067-2017: Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the IFU has a warning indicating the clean

## Indications for use
The EG-3670URK, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Track including but 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 procedure are observed in adult and pediatric patient populations. Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows

Source page: https://510kreport.com/device/K090196
Methodology: https://510kreport.com/methodology