Cleared Traditional

Processor VP-7000, Light Source BL-7000

K163675 · Fujifilm Medical System U.S.A., Inc. · Gastroenterology & Urology

Apr 2017

Decision

119d

Days

Class 2

Risk

About This 510(k) Submission

K163675 is an FDA 510(k) clearance for the Processor VP-7000, Light Source BL-7000, a Endoscopic Video Imaging System/component, Gastroenterology-urology (Class II — Special Controls, product code FET), submitted by Fujifilm Medical System U.S.A., Inc. (Wayne, US). The FDA issued a Cleared decision on April 25, 2017, 119 days after receiving the submission on December 27, 2016. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K163675 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 27, 2016
Decision Date	April 25, 2017
Days to Decision	119 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.