EW10-EC02 Endoscopy Support Program— 510(k) K230751

Name: FDA 510(k) clearance K230751
Creator: U.S. Food and Drug Administration
Published: 2023-12-15

Substantially Equivalent

Fujifilm Corporation

FDA 510(k) clearance K230751 for EW10-EC02 Endoscopy Support Program, Substantially Equivalent on 2023-12-15. 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: 2023-03-17
Decision date: 2023-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ashigara Kami-Gun, JP

Download summary PDF View on FDA.gov ↗

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K260724 — MAGENTIQ-COLO (ME-APDS)2026-04-03

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