K994344

Substantially Equivalent

NEUROTHERM RF CANNULA

Applicant
Rocket Medical Plc
Product code
GXI
Advisory panel
Neurology
Date received
Decision date
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, through . 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.