SMITH & NEPHEW RF CANNULATE— 510(k) K090955

Substantially Equivalent

Smith & Nephew, Inc.

FDA 510(k) clearance K090955 for SMITH & NEPHEW RF CANNULATE, Substantially Equivalent on 2009-07-16. Applicant: Smith & Nephew, Inc..

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code GXI
Advisory panel: Neurology
Date received: 2009-04-06
Decision date: 2009-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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.