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FDA 510(k)

FUJIFILM Ultrasonic Endoscope EB-710US

K-Number: K250863 · 2025-12-12

Decision Date2025-12-12
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

FUJIFILM Ultrasonic Endoscope EB-710US is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2025-12-12 under approval number K250863. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJIFILM Ultrasonic Endoscope EB-710US?

FUJIFILM Ultrasonic Endoscope EB-710US is a medical device that received FDA 510(k) clearance on 2025-12-12. It is manufactured by Fujifilm Corporation. The 510(k) number is K250863.

When was FUJIFILM Ultrasonic Endoscope EB-710US approved by the FDA?

FUJIFILM Ultrasonic Endoscope EB-710US received FDA 510(k) clearance on 2025-12-12, under approval number K250863.

What company makes FUJIFILM Ultrasonic Endoscope EB-710US?

FUJIFILM Ultrasonic Endoscope EB-710US is manufactured by Fujifilm Corporation.

What is the FDA product code for FUJIFILM Ultrasonic Endoscope EB-710US?

The FDA product code for FUJIFILM Ultrasonic Endoscope EB-710US is EOQ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.