510(k) K201945

KARL STORZ UDEL Sterilization Trays by Karl Storz Endoscopy America, Inc. — Product Code KCT

K201945 is an FDA 510(k) premarket notification submitted by Karl Storz Endoscopy America, Inc. for the device "KARL STORZ UDEL Sterilization Trays". The FDA issued a decision of Substantially Equivalent on February 25, 2021. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Karl Storz Endoscopy America, Inc. has at least 10 other 510(k) clearances on record.