510(k) K172960

easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use by Ezisurg Medical Co., Ltd. — Product Code GDW

K172960 is an FDA 510(k) premarket notification submitted by Ezisurg Medical Co., Ltd. for the device "easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use". The FDA issued a decision of Substantially Equivalent on Dec 21, 2017. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Ezisurg Medical Co., Ltd. has 4 other 510(k) clearances on record.