510(k) K162707

Single Use Circular Stapler, Single Use Hemorrhoidal 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 Golden Stapler Surgical Co., Ltd. — Product Code GDW

K162707 is an FDA 510(k) premarket notification submitted by Golden Stapler Surgical Co., Ltd. for the device "Single Use Circular Stapler, Single Use Hemorrhoidal 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 Jul 14, 2017. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750.