Cleared Traditional

FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R

K243260 · Fujifilm Corporation · Gastroenterology & Urology

Apr 2025

Decision

178d

Days

Class 2

Risk

About This 510(k) Submission

K243260 is an FDA 510(k) clearance for the FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R, a Endoscopic Video Imaging System/component, Gastroenterology-urology (Class II — Special Controls, product code FET), submitted by Fujifilm Corporation (Ashigara Kami-Gun, JP). The FDA issued a Cleared decision on April 11, 2025, 178 days after receiving the submission on October 15, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K243260 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 15, 2024
Decision Date	April 11, 2025
Days to Decision	178 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	FET — Endoscopic Video Imaging System/component, Gastroenterology-urology
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor.