510(k) K122044

STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR by Advanced Sterilization Products — Product Code FRC

K122044 is an FDA 510(k) premarket notification submitted by Advanced Sterilization Products for the device "STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR". The FDA issued a decision of Substantially Equivalent on October 4, 2012. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Advanced Sterilization Products has at least 10 other 510(k) clearances on record.