Cleared Special

VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM (K131434) - FDA 510(k) Clearance

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K131434 · Visionsense, Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
60d
Days
Class 2
Risk

K131434 is an FDA 510(k) clearance for the VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM. Classified as Endoscope, Neurological (product code GWG), Class II - Special Controls.

Submitted by Visionsense, Ltd. (Washington, US). The FDA issued a Cleared decision on July 16, 2013 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1480 - the FDA neurology 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 Visionsense, Ltd. devices

Submission Details

510(k) Number K131434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2013
Decision Date July 16, 2013
Days to Decision 60 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 148d · This submission: 60d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GWG Endoscope, Neurological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1480
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Neurology devices follow this clearance model.

Regulatory Peers - GWG Endoscope, Neurological

All 46
Devices cleared under the same product code (GWG) and FDA review panel - the closest regulatory comparables to K131434.
TIPCAM 1S 3D System
K162880 · KARL STORZ Endoscopy-America, Inc. · Mar 2017
KARL STORZ Flexible Video-Neuro-Endoscope System
K161112 · KARL STORZ Endoscopy-America, Inc. · Sep 2016
MINOP Disposable Introducer 26F
K142315 · Aesculap, Inc. · Nov 2014
KSEA CLEARVISION II, MODEL 40334120
K072410 · KARL STORZ Endoscopy-America, Inc. · May 2008
NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELEMENTS, BIPOLAR AND UNIPOLAR ELECTRODES
K031858 · Richard Wolf Medical Instruments Corp. · Jul 2004
ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452
K022198 · Richard Wolf Medical Instruments Corp. · Mar 2003