510(k) K210909

easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use by Ezisurg Medical Co., Ltd. — Product Code GDW

K210909 is an FDA 510(k) premarket notification submitted by Ezisurg Medical Co., Ltd. for the device "easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use". The FDA issued a decision of Substantially Equivalent on Jun 24, 2021. 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.