510(k) K173259

Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories by Case Medical, Inc. — Product Code KCT

K173259 is an FDA 510(k) premarket notification submitted by Case Medical, Inc. for the device "Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories". The FDA issued a decision of Substantially Equivalent on June 13, 2018. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Case Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2018
Date Received
October 10, 2017
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