510(k) K143115

The VersaJet II Hydrosurgery System by Smith & Nephew, Inc. — Product Code FQH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2015
Date Received
October 30, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lavage, Jet
Device Class
Class II
Regulation Number
880.5475
Review Panel
HO
Submission Type