PZR — Percutaneous Nerve Stimulator For Opioid Withdrawal Class II
FDA product code PZR covers "Percutaneous Nerve Stimulator For Opioid Withdrawal", a Class II medical device regulated under 21 CFR 882.5896. Submissions are reviewed by the Neurology panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PZR
- Device Class
- Class II
- Regulation Number
- 882.5896
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Definition
Stimulate nerve branches to aid in the reduction of symptoms associated with substance use disorders.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251246 | spark biomedical | Sparrow Ascent | August 25, 2025 |
| K233166 | net recovery | NET Recovery Corp/NET Device | May 29, 2024 |
| K230796 | spark biomedical | Sparrow Ascent | June 20, 2023 |
| K221231 | dyansys | Drug Relief v1 | June 6, 2022 |
| K211971 | dyansys | Drug Relief v1 | November 5, 2021 |
| K201873 | spark biomedical | Sparrow Therapy System | January 2, 2021 |
| K173861 | dyansys | Drug Relief | May 2, 2018 |
| DEN170018 | innovative health solutions (ihs) | NSS-2 System | November 15, 2017 |