510(k) K192963

Kogent Torus Ultrasonic Aspirator by Katalyst Surgical, LLC — Product Code LFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2020
Date Received
October 23, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Ultrasonic Surgical
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type