StimTrial Neuromodulation System— 510(k) K243782

Substantially Equivalent

Bioventus, LLC

FDA 510(k) clearance K243782 for StimTrial Neuromodulation System, Substantially Equivalent on 2025-07-16. Applicant: Bioventus, LLC.

Clearance details

Applicant: Bioventus, LLC
Product code: Code GZF
Advisory panel: Neurology
Date received: 2024-12-09
Decision date: 2025-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

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.