UNIVERSAL NEURO 3 SYSTEM— 510(k) K131775

Substantially Equivalent

Stryker

FDA 510(k) clearance K131775 for UNIVERSAL NEURO 3 SYSTEM, Substantially Equivalent on 2013-10-17. Applicant: Stryker.

Clearance details

Applicant: Stryker
Product code: Code GWO
Advisory panel: Neurology
Date received: 2013-06-17
Decision date: 2013-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portage, MI, US

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Adverse events under product code GWO

product code GWO

Malfunction: 583
Total: 583

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.