StimRouter Neuromodulation System— 510(k) K211965

Substantially Equivalent

Bioness, Inc.

FDA 510(k) clearance K211965 for StimRouter Neuromodulation System, Substantially Equivalent on 2022-02-23. Applicant: Bioness, Inc..

Clearance details

Applicant: Bioness, Inc.
Product code: Code GZF
Advisory panel: Neurology
Date received: 2021-06-24
Decision date: 2022-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valencia, CA, US

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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.