Cleared Traditional

gammaCore-S (K173442) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence.

K173442 · Electrocore, LLC · Neurology device
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Optimized for regulatory review, auditing and printing
Jan 2018
Decision
78d
Days
Class 2
Risk

K173442 is an FDA 510(k) clearance for the gammaCore-S. 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 January 23, 2018 after a review of 78 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Electrocore, LLC devices

Submission Details

510(k) Number K173442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2017
Decision Date January 23, 2018
Days to Decision 78 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 148d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02686034 Completed Interventional Industry-sponsored

RCT of Non-Invasive Vagus Nerve Stimulation (nVNS) With gammaCore®, for the Acute Treatment of Migraine Attacks

A Prospective, Multi-centre, Randomized, Double-blind, Sham-controlled Study of gammaCore® Non-invasive Vagus Nerve Stimulator (nVNS), for the Acute Treatment of Migraine

285
Patients (actual)
10
Sites
Treatment
Purpose
Quadruple
Masking
Condition studied Migraine
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Cristina Tassorelli, MD, PhD
Sponsor ElectroCore INC (industry)
Started 2016-01-01 → Primary completion 2016-12-01 → Completed 2017-03-01
Primary outcome
Number of Participants With Treatment Response - No Pain
Secondary outcome
Number of Participants With Absence of Nausea/Vomiting, Photophobia, Phonophobia
View full study on ClinicalTrials.gov