GammaCore Sapphire
Non-invasive Vagus Nerve Stimulator - Headache
Electrocore, Inc.
The following data is part of a premarket notification filed by Electrocore, Inc. with the FDA for Gammacore Sapphire.
Pre-market Notification Details
| Device ID | K211856 |
| 510k Number | K211856 |
| Device Name: | GammaCore Sapphire |
| Classification | Non-invasive Vagus Nerve Stimulator - Headache |
| Applicant | Electrocore, Inc. 200 Forge Way, Suite 205 Rockaway, NJ 07866 |
| Contact | Mike Romaniw |
| Correspondent | Mike Romaniw Electrocore, Inc. 200 Forge Way, Suite 205 Rockaway, NJ 07866 |
| Product Code | PKR |
| CFR Regulation Number | 882.5892 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-16 |
| Decision Date | 2021-09-10 |
Trademark Results [GammaCore Sapphire]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GAMMACORE SAPPHIRE 87519426 5897664 Live/Registered |
Electrocore LLC 2017-07-07 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.