Not Cleared Direct

DEN150048 - gammaCore Non-invasive Vagus Nerve Stimulator (FDA 510(k) Clearance)

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

DEN150048 · Electrocore, LLC · Neurology device
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Apr 2017
Decision
546d
Days
Class 2
Risk

DEN150048 is an FDA 510(k) submission (not cleared) for the gammaCore Non-invasive Vagus Nerve Stimulator. Classified as Non-invasive Vagus Nerve Stimulator - Headache (product code PKR), Class II - Special Controls.

Submitted by Electrocore, LLC (Basking Ridge, US). The FDA issued a Not Cleared (DENG) decision on April 14, 2017 after a review of 546 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5892 - the FDA neurology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 546 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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Submission Details

510(k) Number DEN150048 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received October 16, 2015
Decision Date April 14, 2017
Days to Decision 546 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
398d slower than avg
Panel avg: 148d · This submission: 546d
Pathway characteristics

Device Classification

Product Code PKR Non-invasive Vagus Nerve Stimulator - Headache
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5892
Definition The Device Intended For Non-invasive Vagus Nerve Stimulation (nvns) On The Side Of The Neck To Treat Cluster Headache And To Reduce The Frequency Of Cluster Headache Attacks.
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.