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 Dyansys, Inc., Spark Biomedical, Inc. and Net Recovery.
8
Total
7
Cleared
148d
Avg days
2017
Since
Declining activity -
1 submissions in the last 2 years
vs 2 in the prior period
Review times improving: avg
125d
recently vs 152d historically
FDA 510(k) Cleared Percutaneous Nerve Stimulator For Opioid Withdrawal Devices (Product Code PZR)
8 devices
Cleared
Aug 25, 2025
Sparrow Ascent
Spark Biomedical, Inc.
Neurology
125d
Cleared
May 29, 2024
NET Recovery Corp/NET Device
Net Recovery
Neurology
245d
Cleared
Jun 20, 2023
Sparrow Ascent
Spark Biomedical, Inc.
Neurology
90d
Cleared
Jun 06, 2022
Drug Relief v1
Dyansys, Inc.
Neurology
38d
Cleared
Nov 05, 2021
Drug Relief v1
Dyansys, Inc.
Neurology
134d
Cleared
Jan 02, 2021
Sparrow Therapy System
Spark Biomedical, Inc.
Neurology
179d
Cleared
May 02, 2018
Drug Relief
Dyansys, Inc.
Neurology
133d
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 declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA 510(k) Review Time - PZR Product Code
Recent submissions under PZR have taken an average of 125 days to reach a decision - down from 152 days historically, suggesting improved FDA processing for this classification.
PZR devices are reviewed by the Neurology panel. Browse all Neurology devices →