510(k) K230796 ยท PZR Percutaneous Nerve Stimulator For Opioid Withdrawal
Sparrow Ascent
| Applicant | Spark Biomedical, Inc., Dallas TX, US |
| Decision | Substantially Equivalent, Jun 20, 2023 |
| Received | Mar 22, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230796
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 11, 2025 | Spark Biomedical Inc Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28 Open, Classified |
PZR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.