K211607 - SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
(FDA 510(k) Clearance)

K211607 is an FDA 510(k) clearance for the SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate, a Sterilant, Medical Devices (Class II — Special Controls, product code MED), submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on September 7, 2021, 105 days after receiving the submission on May 25, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6885.