FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
gammaCore Sapphire
K Number: K203546
·
Decision Feb 12, 2021
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
8
Applicant Total
4
Review Days
70
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- gammaCore Sapphire
- K Number
- K203546
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5892
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Electrocore, Inc.
- Date Received
- December 4, 2020
- Decision Date
- February 12, 2021
- Product Code
- PKR
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PKR | Non-Invasive Vagus Nerve Stimulator - Headache | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PKR), ordered by most recent decision date.
gammaCore Sapphire
FDA 510(k)
FDA Class 2
·Neurology
gammaCore Sapphire
FDA 510(k)
FDA Class 2
·Neurology
gammaCore Sapphire
FDA 510(k)
FDA Class 2
·Neurology
gammaCore Sapphire
FDA 510(k)
FDA Class 2
·Neurology
gammaCore-S
FDA 510(k)
FDA Class 2
·Neurology
gammaCore-2
FDA 510(k)
FDA Class 2
·Neurology