510(k) K181657

easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use by Ezisurg Medical Co., Ltd. — Product Code GDW

K181657 is an FDA 510(k) premarket notification submitted by Ezisurg Medical Co., Ltd. for the device "easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use". The FDA issued a decision of Substantially Equivalent on Feb 1, 2019. 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.