FDA Registration
Active
🇺🇸 United States
Spark Biomedical Inc.
Reg #: 3017987352
·
FEI: 3017987352
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- Spark Biomedical Inc.
- Registration Number
- 3017987352
- FEI Number
- 3017987352
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7535 W Grand Pkwy S
- City
- Richmond
- State
- TX
- ZIP
- 77407
- Country
- US
Regulatory Submissions
- 510(k) Number
- K251246
Owner / Operator
- Firm Name
- Spark Biomedical Inc
- Operator Number
- 10080441
- Address
- 18208 Preston Road, Ste D9-531
- City
- Dallas
- State
- TX
- Postal Code
- 75252
- Country
- US
- Correspondent
- Brent Croft
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Percutaneous Nerve Stimulator For Opioid Withdrawal | PZR | Class 2 | Neurology | No | 2026-01-08 |
Proprietary Names
Sparrow Ascent
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198