# K021278: EG-3630UR, Ultrasound Video Gastroscope

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Precision Instrument Corp.
- Decided: Sep 6, 2002 after 137 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: 3 generations back to K812810 (1981). 7 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010740: FG-36UX, Fiber Ultrasound Gastroscope, Pentax Precision Instrument Corp. (2001) Summary page 4.
- K994026: Eub-6000 Ultrasound Diagnostic Scanner, Hitachi Medical Corp. of America (2000) Summary page 4.

## Most influential descendants
- K023401: EG-3830UT, Video Ultrasound Gastroscope (2003), 9 descendants of its own
- K090197: EG-3870UTK (2009), 6 descendants of its own
- K130247: Pentax EG-3870UTK Ultrasound Video Gastroscope + HI Vision Preirus (2013), 5 descendants of its own
- K162447: PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner (2017), 4 descendants of its own
- K182004: PENTAX Medical Endoscopic Ultrasound System (2018), 3 descendants of its own

## Indications for use
The EG-3630UR, 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/K021278
Methodology: https://510kreport.com/methodology