Cleared Special

K081585 - ENDOSCOPY VIDEO CAMERA SYSTEM

K081585 is an FDA 510(k) clearance for ENDOSCOPY VIDEO CAMERA SYSTEM, manufactured by Vision Systems Group, A Division of Viking Systems. The device is a Class 2 Gastroenterology & Urology device with product code FET cleared through the Special 510(k) pathway after a 15-day FDA review.

K081585 · Vision Systems Group, A Division of Viking Systems · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
15d
Days
Class 2
Risk

K081585 is an FDA 510(k) clearance for the ENDOSCOPY VIDEO CAMERA SYSTEM. Classified as Endoscopic Video Imaging System/component, Gastroenterology-urology (product code FET), Class II - Special Controls.

Submitted by Vision Systems Group, A Division of Viking Systems (South Grafton, US). The FDA issued a Cleared decision on June 20, 2008 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Vision Systems Group, A Division of Viking Systems devices

FDA 510(k) Submission Details - K081585

510(k) Number K081585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2008
Decision Date June 20, 2008
Days to Decision 15 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 130d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

FET Device Classification - Class 2, Special Controls

Product Code FET Endoscopic Video Imaging System/component, Gastroenterology-urology
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FET Endoscopic Video Imaging System/component, Gastroenterology-urology

All 58
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