510(k) K251246 ยท PZR Percutaneous Nerve Stimulator For Opioid Withdrawal
Sparrow Ascent
| Applicant | Spark Biomedical, Inc., Dallas TX, US |
| Decision | Substantially Equivalent, Aug 25, 2025 |
| Received | Apr 22, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251246
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.