System 1 endo Liquid Chemical Sterilant Processing System

System 1 endo Liquid Chemical Sterilant Processing System is an FDA 510(k)-cleared medical device (K173256) manufactured by STERIS 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 March 1, 2018. Regulation: 8.