510(k) K221492

SteriTite Container System with MediTray Parts by Case Medical, Inc. — Product Code KCT

K221492 is an FDA 510(k) premarket notification submitted by Case Medical, Inc. for the device "SteriTite Container System with MediTray Parts". The FDA issued a decision of Substantially Equivalent on October 7, 2022. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Case Medical, Inc. has at least 10 other 510(k) clearances on record.