Home / Companies / Electrocore, Inc.

Electrocore, Inc.

FDA Regulatory Profile

Electrocore, Inc. has 0 FDA recalls, 0 inspections, 8 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Sep 10, 2021

Reviewing Electrocore, Inc. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Request a free FDA snapshot

Or get Electrocore, Inc.'s full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site, in Claude, Cursor or ChatGPT.

Get a free API key

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances8Oct 4, 2026Not statedCurrent
Inspections0Oct 23, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K211856gammaCore SapphireSep 10, 2021
K203546gammaCore SapphireFeb 12, 2021
K191830gammaCore SapphireMar 26, 2020
K182369gammaCore SapphireNov 27, 2018
K180538gammaCore SapphireMar 30, 2018
K173442gammaCore-SJan 23, 2018
K171306gammaCore-SMay 30, 2017
DEN150048gammaCore Non-invasive Vagus Nerve StimulatorApr 14, 2017

FDA data resources