Freedom Peripheral Nerve Stimulator (PNS) System— 510(k) K233162

Name: FDA 510(k) clearance K233162
Creator: U.S. Food and Drug Administration
Published: 2024-06-20

Substantially Equivalent

Curonix

FDA 510(k) clearance K233162 for Freedom Peripheral Nerve Stimulator (PNS) System, Substantially Equivalent on 2024-06-20. Applicant: Curonix. Device class: 2.

Clearance details

Applicant: Curonix
Product code: Code GZF
Device class: Class 2
Regulation: 21 CFR 882.5870
Advisory panel: Neurology
Date received: 2023-09-27
Decision date: 2024-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pompano Beach, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GZF

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K253877 — StimTrial Neuromodulation System2026-08-26
K243782 — StimTrial Neuromodulation System2025-07-16
K243678 — TalisMann Neuromodulation System2025-07-03
K232415 — Nalu Neurostimulation System for Peripheral Nerve Stimulation2024-08-21
K221303 — Neuspera Nuity System2023-04-11

Adverse events under product code GZF

product code GZF

Death: 10
Injury: 2,410
Other: 1
Total: 2,421

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.