gammaCore Sapphire
FDA 510(k) clearance K211856 · decided 2021-09-10
Clearance details
- K-number
- K211856
- Device name
- gammaCore Sapphire
- Applicant
- Electrocore, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-06-16
- Decision date
- 2021-09-10
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- PKR
- Device class
- 2
- Regulation number
- 882.5892
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Rockaway, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| gammaCore Sapphire (K203546) | Electrocore, Inc. | 2021-02-12 |
| gammaCore Sapphire (K191830) | Electrocore, Inc. | 2020-03-26 |
| gammaCore Sapphire (K182369) | Electrocore, Inc. | 2018-11-27 |
| gammaCore Sapphire (K180538) | Electrocore, LLC | 2018-03-30 |
| gammaCore-S (K173442) | Electrocore, LLC | 2018-01-23 |
| gammaCore-2 (K172270) | Eletrocore, LLC | 2017-12-07 |
| gammaCore-S (K171306) | Electrocore, LLC | 2017-05-30 |
| gammaCore Non-invasive Vagus Nerve Stimulator (DEN150048) | Electrocore, LLC | 2017-04-14 |
Recalls involving this device
No recalls on record reference this clearance.