510(k) K162710

Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload by Tgs Medical Co., Ltd. — Product Code GDW

K162710 is an FDA 510(k) premarket notification submitted by Tgs Medical Co., Ltd. for the device "Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload". The FDA issued a decision of Substantially Equivalent on Feb 9, 2017. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750.