510(k) K160818

STERRAD® NX Sterilizer with ALLClear™ Technology by Advanced Sterilization Products — Product Code MLR

K160818 is an FDA 510(k) premarket notification submitted by Advanced Sterilization Products for the device "STERRAD® NX Sterilizer with ALLClear™ Technology". The FDA issued a decision of Substantially Equivalent on September 27, 2016. The device falls under product code MLR (Sterilizer, Chemical), a Class II device regulated under 21 CFR 880.6860. Advanced Sterilization Products has at least 10 other 510(k) clearances on record.