Cleared Traditional

THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525

K130423 · Richard Wolf Medical Instruments Corp. · Gastroenterology & Urology

Apr 2013

Decision

42d

Days

Class 2

Risk

About This 510(k) Submission

K130423 is an FDA 510(k) clearance for the THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525, a Endoscopic Video Imaging System/component, Gastroenterology-urology (Class II — Special Controls, product code FET), submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on April 3, 2013, 42 days after receiving the submission on February 20, 2013. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K130423 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 20, 2013
Decision Date	April 03, 2013
Days to Decision	42 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.