510(k) K233222

Aygün Sterilization Container Systems by Aygun Surgical Instruments Co., Inc. — Product Code KCT

K233222 is an FDA 510(k) premarket notification submitted by Aygun Surgical Instruments Co., Inc. for the device "Aygün Sterilization Container Systems". The FDA issued a decision of Substantially Equivalent on December 12, 2023. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850.