IRRAflow Active Fluid Exchange System (AFES)

IRRAflow Active Fluid Exchange System (AFES) is an FDA 510(k)-cleared medical device (K231664) manufactured by Irras USA, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 18, 2023. Regulation: 8.