# K173442: gammaCore-S

- Pathway: 510(k) (Traditional)
- Applicant: Electrocore, LLC
- Decided: Jan 23, 2018 after 78 days
- Product code: PKR (Non-Invasive Vagus Nerve Stimulator - Headache)
- Device class: 2
- Regulation: 21 CFR 882.5892
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN150048 (2017). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171306: gammaCore-S, Electrocore, LLC (2017) Summary page 5.

## Indications for use
The gammaCore-S Non-invasive Vagus Nerve Stimulator is intended to provide noninvasive vagus nerve stimulation (nVNS) on the side of the neck. The gammaCore-S device is indicated for the acute treatment of pain associated with episodic cluster headache and migraine headache in adult patients.

Source page: https://510kreport.com/device/K173442
Methodology: https://510kreport.com/methodology