510(k) K161683

SYSTEM 1E Liquid Chemical Sterilant Processing System by STERIS Corporation — Product Code MED

K161683 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "SYSTEM 1E Liquid Chemical Sterilant Processing System". The FDA issued a decision of Substantially Equivalent on August 5, 2016. The device falls under product code MED (Sterilant, Medical Devices), a Class II device regulated under 21 CFR 880.6885. STERIS Corporation has at least 10 other 510(k) clearances on record.