# K010740: FG-36UX, Fiber Ultrasound Gastroscope

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Precision Instrument Corp.
- Decided: Apr 17, 2001 after 35 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: 2 generations back to K812810 (1981). 6 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have 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 4.
- K994026: Eub-6000 Ultrasound Diagnostic Scanner, Hitachi Medical Corp. of America (2000) Summary page 4.

## Most influential descendants
- K021278: EG-3630UR, Ultrasound Video Gastroscope (2002), 10 descendants of its own
- 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

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows

Source page: https://510kreport.com/device/K010740
Methodology: https://510kreport.com/methodology