K251246 is an FDA 510(k) clearance for the Sparrow Ascent. This device is classified as a Percutaneous Nerve Stimulator For Opioid Withdrawal (Class II - Special Controls, product code PZR).
Submitted by Spark Biomedical, Inc. (Dallas, US). The FDA issued a Cleared decision on August 25, 2025, 125 days after receiving the submission on April 22, 2025.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5896. Stimulate Nerve Branches To Aid In The Reduction Of Symptoms Associated With Substance Use Disorders..
| 510(k) Number | K251246 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 2025 |
| Decision Date | August 25, 2025 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | PZR — Percutaneous Nerve Stimulator For Opioid Withdrawal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5896 |
| Definition | Stimulate Nerve Branches To Aid In The Reduction Of Symptoms Associated With Substance Use Disorders. |