K251246
- 510(k) number
- K251246
- Device name
- Sparrow Ascent
- Applicant
- Spark Biomedical, Inc. TX · US
- Product code
- PZR — Percutaneous Nerve Stimulator For Opioid Withdrawal
- Decision date
- 2025-08-25
- Date received
- 2025-04-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251246.pdf
Official FDA record: K251246
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.