EW10-EC02 Endoscopy Support Program— 510(k) K260567

Name: FDA 510(k) clearance K260567
Creator: U.S. Food and Drug Administration
Published: 2026-08-07

Substantially Equivalent

Fujifilm Corporation

FDA 510(k) clearance K260567 for EW10-EC02 Endoscopy Support Program, Substantially Equivalent on 2026-08-07. Applicant: Fujifilm Corporation. Device class: 2.

Clearance details

Applicant: Fujifilm Corporation
Product code: Code QNP
Device class: Class 2
Regulation: 21 CFR 876.1520
Advisory panel: Gastroenterology, Urology
Date received: 2026-02-19
Decision date: 2026-08-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Ashigarakami-Gun, JP

Download summary PDF View on FDA.gov ↗

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