510(k) K231501

PRO-LITE Sterilization Tray by STERIS Corporation — Product Code KCT

K231501 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "PRO-LITE Sterilization Tray". The FDA issued a decision of Substantially Equivalent on August 7, 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. STERIS Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2023
Date Received
May 24, 2023
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