Cleared Special

K170677 - Neurovision Nerve Locator Monitor (Nerv...

K170677 is an FDA 510(k) clearance for Neurovision Nerve Locator Monitor (Nerv..., manufactured by Neurovision Medical Product, Inc.. The device is a Class 2 Neurology device with product code GWF cleared through the Special 510(k) pathway after a 30-day FDA review.

K170677 · Neurovision Medical Product, Inc. · Neurology device
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Apr 2017
Decision
30d
Days
Class 2
Risk

K170677 is an FDA 510(k) clearance for the Neurovision Nerve Locator Monitor (Nerveana), EMGView Software. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Neurovision Medical Product, Inc. (Ventura, US). The FDA issued a Cleared decision on April 5, 2017 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - 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 Neurovision Medical Product, Inc. devices

FDA 510(k) Submission Details - K170677

510(k) Number K170677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2017
Decision Date April 05, 2017
Days to Decision 30 days
Submission Type Special
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

GWF Device Classification - Class 2, Special Controls

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
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 - GWF Stimulator, Electrical, Evoked Response

All 65
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