Duet External Drainage and Monitoring System (EDMS)

Duet External Drainage and Monitoring System (EDMS) is an FDA 510(k)-cleared medical device (K243676) manufactured by Medtronic Neurosurgery. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 9, 2025. Regulation: 8.