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FDA 510(k)

FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T

K-Number: K253137 · 2026-06-16

ApplicantFujifilm Corporation
Decision Date2026-06-16
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2026-06-16 under 510(k) number K253137. 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 Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T?

FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T is a medical device that received FDA 510(k) clearance on 2026-06-16. The listed applicant is Fujifilm Corporation. The 510(k) number is K253137.

When did FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T receive FDA 510(k) clearance?

FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T received FDA 510(k) clearance on 2026-06-16, under 510(k) number K253137.

Who is the listed applicant for FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T?

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 Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T?

The FDA product code for FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T 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.

K260567EW10-EC02 Endoscopy Support ProgramK261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01K254075Synapse Lung Nodule AIK254189Synapse 3D Base Tools (V7.2)K253862APERTO Lucent MRI SystemK251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000

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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.K260565SmartClip 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.K250863FUJIFILM Ultrasonic Endoscope EB-710USFujifilm Corporation

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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