Electrocore, LLC

FDA Regulatory Profile

Electrocore, LLC appears in FDA public data with 0 recalls, 8 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on September 10, 2021.

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K211856gammaCore SapphireSeptember 10, 2021
K203546gammaCore SapphireFebruary 12, 2021
K191830gammaCore SapphireMarch 26, 2020
K182369gammaCore SapphireNovember 27, 2018
K180538gammaCore SapphireMarch 30, 2018
K173442gammaCore-SJanuary 23, 2018
K171306gammaCore-SMay 30, 2017
DEN150048gammaCore Non-invasive Vagus Nerve StimulatorApril 14, 2017