510(k) K192781

UroLift System Procedure Kit Sterilization Tray by Neotract, Inc. — Product Code KCT

K192781 is an FDA 510(k) premarket notification submitted by Neotract, Inc. for the device "UroLift System Procedure Kit Sterilization Tray". The FDA issued a decision of Substantially Equivalent on April 14, 2020. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Neotract, Inc. has at least 10 other 510(k) clearances on record.