510(k) 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 by Beijing Biosis Healing Biolog Ical Technology Co., Ltd. — Product Code GDW

K201639 is an FDA 510(k) premarket notification submitted by Beijing Biosis Healing Biolog Ical Technology Co., Ltd. for the device "Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads". The FDA issued a decision of Substantially Equivalent on May 27, 2021. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Beijing Biosis Healing Biolog Ical Technology Co., Ltd. has at least 6 other 510(k) clearances on record.