510(k) K123017

STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14324 by Advanced Sterilization Products — Product Code FRC

K123017 is an FDA 510(k) premarket notification submitted by Advanced Sterilization Products for the device "STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14324". The FDA issued a decision of Substantially Equivalent on December 26, 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.