# K211856: gammaCore Sapphire

- Pathway: 510(k) (Traditional)
- Applicant: Electrocore, Inc.
- Decided: Sep 10, 2021 after 86 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: 7 generations back to DEN150048 (2017). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203546: gammaCore Sapphire, Electrocore, Inc. (2021) Summary page 4.

## Indications for use
The gammaCore Sapphire Non-invasive Vagus Nerve Stimulator is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. The gammaCore Sapphire device is indicated for: • The preventive treatment of migraine headache in adolescent (aged 12 and older) and adult patients • The acute treatment of pain associated with migraine headache in adolescents (aged 12 and older) and adult patients • Adjunctive use for the preventive treatment of cluster headache in adult patients • The acute treatment of pain associated with episodic cluster headache in adult patients • Treatment of hemicrania continua in adults • Treatment of paroxysmal hemicrania in adults

Source page: https://510kreport.com/device/K211856
Methodology: https://510kreport.com/methodology