510(k) K243317

NUVENTUS NV.C™ Surgical Cassette and Tray by Infinitum Eta, Ltd. — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2025
Date Received
October 22, 2024
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