510(k) K112535

GENESIS REUSABLE RIGID CONTAINER SYSTEM by Carefusion 2200, Inc. — Product Code KCT

K112535 is an FDA 510(k) premarket notification submitted by Carefusion 2200, Inc. for the device "GENESIS REUSABLE RIGID CONTAINER SYSTEM". The FDA issued a decision of Substantially Equivalent on April 27, 2012. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Carefusion 2200, Inc. has at least 10 other 510(k) clearances on record.