# K023401: EG-3830UT, Video Ultrasound Gastroscope

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Precision Instrument Corp.
- Decided: Feb 11, 2003 after 125 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: 4 generations back to K812810 (1981). 10 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021276: FG-36UX Fiber Ultrasound Gastroscope, Pentax Precision Instrument Corp. (2002) Summary page 5.
- K021278: EG-3630UR, Ultrasound Video Gastroscope, Pentax Precision Instrument Corp. (2002) Summary page 5.
- K994026: Eub-6000 Ultrasound Diagnostic Scanner, Hitachi Medical Corp. of America (2000) Summary page 5.
- K013723: Modification to: Eub-6500 Diagnostic Ultrasound Scanner, Hitachi Medical Corp. (2002) Summary page 5.

## Most influential descendants
- 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
- K200090: PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type) (2020), 2 descendants of its own

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

Source page: https://510kreport.com/device/K023401
Methodology: https://510kreport.com/methodology