510(k) K233065

V-PRO maX 2 Low Temperature Sterilization System by Steris — Product Code MLR

K233065 is an FDA 510(k) premarket notification submitted by Steris for the device "V-PRO maX 2 Low Temperature Sterilization System". The FDA issued a decision of Substantially Equivalent on October 20, 2023. The device falls under product code MLR (Sterilizer, Chemical), a Class II device regulated under 21 CFR 880.6860. Steris has at least 10 other 510(k) clearances on record.