510(k) K142529

Genesis Reusable Rigid Container System by Carefusion 2200, Inc. — Product Code KCT

K142529 is an FDA 510(k) premarket notification submitted by Carefusion 2200, Inc. for the device "Genesis Reusable Rigid Container System". The FDA issued a decision of Substantially Equivalent on January 8, 2015. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Carefusion 2200, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2015
Date Received
September 9, 2014
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