Cleared Special

K163558 - Synapsys Ulmer Video Nystagmograph (FDA 510(k) Clearance)

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

K163558 · Synapsys SA · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
94d
Days
Class 2
Risk

K163558 is an FDA 510(k) clearance for the Synapsys Ulmer Video Nystagmograph. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Synapsys SA (Marseille, FR). The FDA issued a Cleared decision on March 23, 2017 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1460 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Synapsys SA devices

Submission Details

510(k) Number K163558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2016
Decision Date March 23, 2017
Days to Decision 94 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
54d faster than avg
Panel avg: 148d · This submission: 94d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GWN Nystagmograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1460
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 - GWN Nystagmograph

All 58
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