StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit— 510(k) K142432

Name: FDA 510(k) clearance K142432
Creator: U.S. Food and Drug Administration
Published: 2015-02-20

Substantially Equivalent

Bioness, Inc.

FDA 510(k) clearance K142432 for StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit, Substantially Equivalent on 2015-02-20. Applicant: Bioness, Inc.. Device class: 2.

Clearance details

Applicant: Bioness, Inc.
Product code: Code GZF
Device class: Class 2
Regulation: 21 CFR 882.5870
Advisory panel: Neurology
Date received: 2014-08-29
Decision date: 2015-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valencia, CA, US

Download summary PDF View on FDA.gov ↗

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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.