# K261183: EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Jul 31, 2026 after 112 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: 5 generations back to K853585 (1986). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251859: EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190), Olympus Medical Systems Corporation (2025) Summary page 5.

## Indications for use
The EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE OLYMPUS GF-UE190 has been designed to be used with diagnostic ultrasound system, video system center, light source, documentation equipment, monitor, endoscopic therapy accessories and other ancillary equipment. The EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE OLYMPUS GF-UE190 is designed for endoscopic real-time ultrasound imaging, and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs. Operator qualifications Appropriately trained healthcare professionals. Device use settings Healthcare facility

Source page: https://510kreport.com/device/K261183
Methodology: https://510kreport.com/methodology