← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
GZF — Stimulator, Peripheral Nerve, Implanted (Pain Relief)
DEVICE CLASS
Class II
REGULATION
21 CFR 882.5870
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
NE
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
2
510(K)/PMA CLEARANCES
510k: 2
0
RECALL ENTRIES
Recent clearances
K243782Bioventus, LLC · 510k2025-07-16
K243678Bioventus, LLC · 510k2025-07-03
Related on SPEQ
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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