SMITH & NEPHEW RF CANNULAE— 510(k) K063467

Substantially Equivalent

Smith & Nephew, Inc.

FDA 510(k) clearance K063467 for SMITH & NEPHEW RF CANNULAE, Substantially Equivalent on 2006-11-21. Applicant: Smith & Nephew, Inc..

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code GXI
Advisory panel: Neurology
Date received: 2006-10-24
Decision date: 2006-11-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Andover, MA, 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.