FDA Product Code PZR: Percutaneous Nerve Stimulator For Opioid Withdrawal
Stimulate Nerve Branches To Aid In The Reduction Of Symptoms Associated With Substance Use Disorders.
Leading manufacturers include Spark Biomedical, Inc., Dyansys, Inc. and Net Recovery.
FDA 510(k) Cleared Percutaneous Nerve Stimulator For Opioid Withdrawal Devices (Product Code PZR)
About Product Code PZR - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code PZR since 2017, with 7 receiving FDA clearance (average review time: 148 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA Review Time
Recent submissions under PZR have taken an average of 185 days to reach a decision - up from 136 days historically. Manufacturers should account for longer review timelines in current project planning.
PZR devices are reviewed by the Neurology panel. Browse all Neurology devices →