Cleared Special

K131434 - VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM (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 90
Devices cleared under the same product code (GWG) and FDA review panel - the closest regulatory comparables to K131434.
HJY VisualNext 3D Endoscopic Vision System
K243429 · Hjy Smart Medical Device Co., Ltd. · May 2025
AURORA® Surgiscope® System (ASX15/60)
K250752 · Integra LifeSciences Corporation · Apr 2025
cCeLL - In vivo
K233391 · VPIX Medical, Inc. · Aug 2024
Digital ClarusScope System, Digital NeuroPEN System
K223615 · Clarus Medical, LLC · Nov 2023
Aurora Surgiscope System
K232618 · Rebound Therapeutics Corporation · Oct 2023
Neuroblade System
K230125 · Clearmind Biomedical · Oct 2023