Irrisept Wound Debridement and Cleansing System

Irrisept Wound Debridement and Cleansing System is an FDA 510(k)-cleared medical device (K202222) manufactured by Irrimax Corporation. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 13, 2020. Regulation: 8.