# K171306: gammaCore-S

- Pathway: 510(k) (Special)
- Applicant: Electrocore, LLC
- Decided: May 30, 2017 after 27 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: 1 generation back to DEN150048 (2017). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN150048: gammaCore Non-invasive Vagus Nerve Stimulator, Electrocore, LLC (2017) Summary page 5.

## Most influential descendants
- K172270: gammaCore-2 (2017), 5 descendants of its own
- K180538: gammaCore Sapphire (2018), 4 descendants of its own
- K182369: gammaCore Sapphire (2018), 3 descendants of its own
- K191830: gammaCore Sapphire (2020), 2 descendants of its own
- K203546: gammaCore Sapphire (2021), 1 descendant of its own

## 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 in adult patients.

Source page: https://510kreport.com/device/K171306
Methodology: https://510kreport.com/methodology