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gammaCore Sapphire SLC Device Kit

electroCore, Inc. · Model 12016-04002 · UDI-DI 00815203020546

PKRQAK Prescription
9
510(k) clearances
1
Adverse events
0
Recalls
1
Facilities

Description

gammaCore Sapphire SLC 93-Day Device Kit is intended to provide nVNS stimulation on side of neck; it is indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.