About This 510(k) Submission
K161905 is an FDA 510(k) clearance for the 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, a Staple, Implantable (Class II — Special Controls, product code GDW), submitted by Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd (Changzhou, CN). The FDA issued a Cleared decision on November 17, 2016, 129 days after receiving the submission on July 11, 2016. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4750.