K203546 is an FDA 510(k) clearance for the gammaCore Sapphire. This device is classified as a Non-invasive Vagus Nerve Stimulator - Headache (Class II - Special Controls, product code PKR).
Submitted by Electrocore, Inc. (Basking Ridge, US). The FDA issued a Cleared decision on February 12, 2021, 70 days after receiving the submission on December 4, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5892. 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..
| 510(k) Number | K203546 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 2020 |
| Decision Date | February 12, 2021 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | PKR - Non-invasive Vagus Nerve Stimulator - Headache |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5892 |
| Definition | 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. |