510(k) K222328

SteriCUBE® Multiple Tray Sterilization Systems by Stericube, LLC — Product Code KCT

K222328 is an FDA 510(k) premarket notification submitted by Stericube, LLC for the device "SteriCUBE® Multiple Tray Sterilization Systems". The FDA issued a decision of Substantially Equivalent on Sep 28, 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 28, 2022
Date Received
Aug 2, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type
510(k)