FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Sparrow Ascent
K Number: K251246
·
Decision Aug 25, 2025
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
7
Applicant Total
3
Review Days
125
Basic Information
- Device Name
- Sparrow Ascent
- K Number
- K251246
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5896
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spark Biomedical, Inc.
- Date Received
- April 22, 2025
- Decision Date
- August 25, 2025
- Product Code
- PZR
- 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 |
|---|---|---|---|
| PZR | Percutaneous Nerve Stimulator For Opioid Withdrawal | FDA class 2 | Neurology |
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