# K250863: FUJIFILM Ultrasonic Endoscope EB-710US

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Corporation
- Decided: Dec 12, 2025 after 266 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K894632 (1989). 66 ancestors in all.
No later device cites it as a predicate yet.
1 of 67 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121035: Fujinon/Fujifilm Ultrasonic Endoscope EB-530US, Fujifilm Medical System U.S.A., Inc. (2012)
- K183525: EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F, Olympus Medical Systems Corp. (2019) Summary page 5.
- K220957: FUJIFILM Endoscope Model EB-710P, Fujifilm Corporaton (2022) Summary page 5.

## Indications for use
This product is an ultrasonic endoscope intended for the observation, diagnosis and endoscopic treatment of the esophagus, trachea, bronchus and lesions adjacent to these structures using ultrasonic images, at medical facilities under the management of physicians. This product is not intended for use on children and infants.

Source page: https://510kreport.com/device/K250863
Methodology: https://510kreport.com/methodology