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FDA PRODUCT CODE · CLASS II

PZR — Percutaneous Nerve Stimulator For Opioid Withdrawal

Stimulate nerve branches to aid in the reduction of symptoms associated with substance use disorders.

DEVICE CLASS
Class II
REGULATION
21 CFR 882.5896
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
NE
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
1
510(K)/PMA CLEARANCES
510k: 1
0
RECALL ENTRIES

Recent clearances

K251246Spark Biomedical, Inc. · 510k2025-08-25

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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