PZR
- Product code
- PZR
- Device name
- Percutaneous Nerve Stimulator For Opioid Withdrawal
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.5896
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 8 (all years; only the last 3 years are listed here)
FDA classification definition
Stimulate nerve branches to aid in the reduction of symptoms associated with substance use disorders.
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251246 | 2025-08-25 | Spark Biomedical, Inc. | Sparrow Ascent | |
| K233166 | 2024-05-29 | Net Recovery | NET Recovery Corp/NET Device |
Official FDA classification page: PZR
Classification and pathway per current FDA publications. Data from openFDA (CC0).