510(k) K161905

Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge by Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd — Product Code GDW

K161905 is an FDA 510(k) premarket notification submitted by Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd for the device "Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge". The FDA issued a decision of Substantially Equivalent on November 17, 2016. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd has at least 2 other 510(k) clearances on record.