Fujifilm Corporation · Class II · Cleared Dec 12, 2025
| K-number | K250863 |
| Device name | FUJIFILM Ultrasonic Endoscope EB-710US |
| Applicant | Fujifilm Corporation |
| Product code | EOQ |
| Device class | Class II |
| Decision date | Dec 12, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 874.4680 |
The FUJIFILM Ultrasonic Endoscope EB-710US is a flexible ultrasonic endoscope designed for observation, diagnosis, and endoscopic treatment of the esophagus, trachea, bronchus, and adjacent lesions using ultrasonic imaging. The device is not intended for use in children and infants and operates at medical facilities under physician supervision.
The device consists of an insertion portion with glass fiber bundles, a CMOS image sensor, an ultrasonic transducer, and an instrument channel; a control portion managing tip angulation; and a connector portion with electronic components. It differs from the predicate in maximum insertion diameter, forceps channel diameter, power supply method, communication method, and some dimensions (distal end diameter, flexible portion diameter, bending capability, and total length), but these differences fall within acceptable ranges compared to reference models.
Not stated in this summary.
The proposed device is substantially equivalent because its ultrasound specifications are similar to the predicate devices, technological differences (CMOS sensor, optical systems, software) do not raise new safety or efficacy concerns, specification differences do not raise new questions, accessories are comparable and tested for compatibility, and minor performance differences between proposed and predicate devices do not indicate new or additional safety issues.
View the full FDA submission: accessdata.fda.gov