# K013640: EG-3630UR, Ultrasund Video Gastroscope

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Precision Instrument Corp.
- Decided: Feb 4, 2002 after 91 days
- Product code: FDS (Gastroscope And Accessories, Flexible/Rigid)
- 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 K822846 (1982). 14 ancestors in all.
9 later devices descend from it; 1 cites it directly.
1 of 24 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961974: FG-36UX, Ultrasound Upper GI Fiberscope, Pentax Precision Instrument Corp. (1997) Summary page 1.
- K961564: EG-2940, Video Gastroscope, Pentax Precision Instrument Corp. (1996) Summary page 1.
- K934918: Epm-3300 Video Processor, Pentax Precision Instrument Corp. (1994) Summary page 1.
- K981434: Eup-OL334 Laparascopicprobe, Hitachi Medical Corp. of America (1998) Summary page 1.
- K994026: Eub-6000 Ultrasound Diagnostic Scanner, Hitachi Medical Corp. of America (2000) Summary page 1.

## Most influential descendants
- K063847: Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700 (2007), 8 descendants of its own
- K111243: Fujinon Ultrasonic Processor (2011), 7 descendants of its own
- K120446: Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2 (2012), 4 descendants of its own
- K181763: FUJIFILM Ultrasonic Endoscope (2018), 3 descendants of its own
- K183433: FUJIFILM Ultrasonic Endoscope (2019), 2 descendants of its own

## Indications for use
The Ultrasound Video Gastroscope EG-3630UR is intended to provide ultrasonic and optical visualization of, and therapeutic access to, the Upper GI tract including esophagus, stomach, duodenum/small bowel in adult and pediatric patient populations.

Source page: https://510kreport.com/device/K013640
Methodology: https://510kreport.com/methodology