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FDA 510(k)

FUJIFILM Ultrasonic Endoscope EB-710US

K-Number: K250863 · 2025-12-12

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

Device Summary

FUJIFILM Ultrasonic Endoscope EB-710US is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2025-12-12 under 510(k) 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. The listed applicant is Fujifilm Corporation. The 510(k) number is K250863.

When did FUJIFILM Ultrasonic Endoscope EB-710US receive FDA 510(k) clearance?

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

Who is the listed applicant for FUJIFILM Ultrasonic Endoscope EB-710US?

The FDA 510(k) record lists Fujifilm Corporation as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Fujifilm Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261170BA-004CCK260567EW10-EC02 Endoscopy Support ProgramK261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TK254075Synapse Lung Nodule AIK254189Synapse 3D Base Tools (V7.2)

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Related Devices (Code: EOQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm CorporationK260565SmartClip Delivery Catheter (ADR-1715)Elucent MedicalK252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)Olympus Medical Systems Corp.K260420LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)MacroLux Medical Technology Co., Ltd.

Official Source

View on FDA Database →

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

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