Medical Device Manufacturer · US , Basking Ridge , NJ

Electrocore, LLC - FDA 510(k) Cleared Devices

4 submissions · 3 cleared · Since 2017

Recent clearances: gammaCore Sapphire, gammaCore-S, gammaCore-S

View 4 510(k) Devices ↓

4

Total

3

Cleared

1

Denied

FDA 510(k) Regulatory Record - Electrocore, LLC Neurology ✕

4 devices

1-4 of 4

Cleared Mar 30, 2018

gammaCore Sapphire

Neurology · 30d

Cleared CT Jan 23, 2018

Neurology · 78d

Cleared May 30, 2017

Neurology · 27d

Not Cleared Apr 14, 2017

gammaCore Non-invasive Vagus Nerve Stimulator

DEN150048 · PKR

Neurology · 546d

Data Source

Sourced from the FDA 510(k) public files . 176,583 total devices indexed.

Last updated: Jun 08, 2026