510(k) K190104

SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System by Steris Corporations — Product Code MED

K190104 is an FDA 510(k) premarket notification submitted by Steris Corporations for the device "SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System". The FDA issued a decision of Substantially Equivalent on March 22, 2019. The device falls under product code MED (Sterilant, Medical Devices), a Class II device regulated under 21 CFR 880.6885. Steris Corporations has at least 6 other 510(k) clearances on record.