510(k) K162947

Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit; Linear Cutting Stapler and Single Use Loading Unit; Disposal Hemorrhoidal Circular Stapler by Chongqing Qmi Surgical Co., Ltd. — Product Code GDW

K162947 is an FDA 510(k) premarket notification submitted by Chongqing Qmi Surgical Co., Ltd. for the device "Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit; Linear Cutting Stapler and Single Use Loading Unit; Disposal Hemorrhoidal Circular Stapler". The FDA issued a decision of Substantially Equivalent on Mar 3, 2017. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750.