510(k) K253187

SteriBest® Sterilization Tray System by Mastel Surgical — Product Code KCT

K253187 is an FDA 510(k) premarket notification submitted by Mastel Surgical for the device "SteriBest® Sterilization Tray System". The FDA issued a decision of Substantially Equivalent on June 18, 2026. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850.