510(k) K230582

SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 by STERIS Corporation — Product Code MED

K230582 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900". The FDA issued a decision of Substantially Equivalent on March 28, 2023. 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.