510(k) K182827

SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 by STERIS Corporation — Product Code MED

K182827 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900". The FDA issued a decision of Substantially Equivalent on January 31, 2019. 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.