510(k) K122735

SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2 by Sorin Group USA, Inc. — Product Code GAT

K122735 is an FDA 510(k) premarket notification submitted by Sorin Group USA, Inc. for the device "SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2". The FDA issued a decision of Substantially Equivalent on May 21, 2013. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Sorin Group USA, Inc. has at least 1 other 510(k) clearance on record.