Cleared Special

K180538 - gammaCore Sapphire (FDA 510(k) Clearance)

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

K180538 · Electrocore, LLC · Neurology device
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Optimized for regulatory review, auditing and printing
Mar 2018
Decision
30d
Days
Class 2
Risk

K180538 is an FDA 510(k) clearance for the gammaCore Sapphire. 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 Cleared decision on March 30, 2018 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5892 - 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 Electrocore, LLC devices

Submission Details

510(k) Number K180538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2018
Decision Date March 30, 2018
Days to Decision 30 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
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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.