STRYKER RF ELECTRODES AND CANNULAE— 510(k) K032406

Substantially Equivalent

Stryker Instruments

FDA 510(k) clearance K032406 for STRYKER RF ELECTRODES AND CANNULAE, Substantially Equivalent on 2004-04-01. Applicant: Stryker Instruments.

Clearance details

Applicant: Stryker Instruments
Product code: Code GXI
Advisory panel: Neurology
Date received: 2003-08-04
Decision date: 2004-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalamazoo, MI, US

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Adverse events under product code GXI

product code GXI

Death: 3
Injury: 171
Total: 174

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.