K201639 - Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads
(FDA 510(k) Clearance)

K201639 is an FDA 510(k) clearance for the Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads, a Staple, Implantable (Class II — Special Controls, product code GDW), submitted by Beijing Biosis Healing Biolog Ical Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on May 27, 2021, 345 days after receiving the submission on June 16, 2020. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4750.