FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T— 510(k) K253137

Name: FDA 510(k) clearance K253137
Creator: U.S. Food and Drug Administration
Published: 2026-06-16

Substantially Equivalent

Fujifilm Corporation

FDA 510(k) clearance K253137 for FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T, Substantially Equivalent on 2026-06-16. Applicant: Fujifilm Corporation. Device class: 2.

Clearance details

Applicant: Fujifilm Corporation
Product code: Code EOQ
Device class: Class 2
Regulation: 21 CFR 874.4680
Advisory panel: Ear, Nose, Throat
Date received: 2025-09-25
Decision date: 2026-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ashigara Kami-Gun, JP

Download summary PDF View on FDA.gov ↗

Recent devices under product code EOQ

view all

K260382 — MONARCH Platform (MON-000008)2026-07-25
K254037 — LungFlow Airway Catheter2026-07-10
K260565 — SmartClip Delivery Catheter (ADR-1715)2026-05-14
K252341 — EVIS EXERA III BRONCHOVIDEOSCOPE (3 models)2026-04-23
K260420 — LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)2026-04-08

More clearances from Fujifilm Corporation

view all

K261170 — BA-004CC2026-08-12
K260567 — EW10-EC02 Endoscopy Support Program2026-08-07
K261880 — FUJIFILM Processor EP-8000; Balloon Controller PB-30; Endoscopy Support Program EW10-VM012026-07-02
K254075 — Synapse Lung Nodule AI2026-05-27
K254189 — Synapse 3D Base Tools (V7.2)2026-04-30

Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.