510(k) K190840

Medtronic Transportation / Sterilization Cassettes by Medtronic Sofamor Danek USA, Inc. — Product Code KCT

K190840 is an FDA 510(k) premarket notification submitted by Medtronic Sofamor Danek USA, Inc. for the device "Medtronic Transportation / Sterilization Cassettes". The FDA issued a decision of Substantially Equivalent on Oct 15, 2019. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Medtronic Sofamor Danek USA, Inc. has 181 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 15, 2019
Date Received
Apr 1, 2019
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)