510(k) DEN150048
DEN150048 is an FDA 510(k) premarket notification submitted by Electrocore, LLC for the device "gammaCore Non-invasive Vagus Nerve Stimulator". The FDA issued a decision of De Novo Granted on April 14, 2017. The device falls under product code PKR (Non-Invasive Vagus Nerve Stimulator - Headache), a Class II device regulated under 21 CFR 882.5892. Electrocore, LLC has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 14, 2017
- Date Received
- October 16, 2015
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Non-Invasive Vagus Nerve Stimulator - Headache
- Device Class
- Class II
- Regulation Number
- 882.5892
- Review Panel
- NE
- Submission Type
The device intended for non-invasive vagus nerve stimulation (nVNS) on the side of the neck to treat cluster headache and to reduce the frequency of cluster headache attacks.