# K041395: EG-3630UR

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Precision Instrument Corp.
- Decided: Jun 9, 2004 after 14 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- 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). 9 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 14 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 1.
- K032503: Eub-5500 Diagnostic Ultrasound Scanner, Hitachi Medical Systems America, Inc. (2003) Summary page 1.
- K013722: Modification to: Eub-8500 Diagnostic Ultrasound Scanner, Hitachi Medical Corp. (2002) Summary page 1.

## Most influential descendants
- K061068: EG-3670URK (2006), 3 descendants of its own
- K090196: EG-3670URK (2009), 2 descendants of its own
- 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

## 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. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows

Source page: https://510kreport.com/device/K041395
Methodology: https://510kreport.com/methodology