NEUROTHERM RF CANNULA— 510(k) K994344

Substantially Equivalent

Rocket Medical Plc

FDA 510(k) clearance K994344 for NEUROTHERM RF CANNULA, Substantially Equivalent on 2000-03-21. Applicant: Rocket Medical Plc.

Clearance details

Applicant: Rocket Medical Plc
Product code: Code GXI
Advisory panel: Neurology
Date received: 1999-12-22
Decision date: 2000-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, Tyne & Wear, GB

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.