StimTrial Neuromodulation System— 510(k) K253877

Name: FDA 510(k) clearance K253877
Creator: U.S. Food and Drug Administration
Published: 2026-08-26

Substantially Equivalent

Bioventus, LLC

FDA 510(k) clearance K253877 for StimTrial Neuromodulation System, Substantially Equivalent on 2026-08-26. Applicant: Bioventus, LLC. Device class: 2.

Clearance details

Applicant: Bioventus, LLC
Product code: Code GZF
Device class: Class 2
Regulation: 21 CFR 882.5870
Advisory panel: Neurology
Date received: 2025-12-04
Decision date: 2026-08-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

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K233162 — Freedom Peripheral Nerve Stimulator (PNS) System2024-06-20
K221303 — Neuspera Nuity System2023-04-11

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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.