510(k) K211197

Disposable Endoscopic Cutter Stapler and Cartridge by Changzhou Waston Medical Appliance Co., Ltd. — Product Code GDW

K211197 is an FDA 510(k) premarket notification submitted by Changzhou Waston Medical Appliance Co., Ltd. for the device "Disposable Endoscopic Cutter Stapler and Cartridge". The FDA issued a decision of Substantially Equivalent on January 19, 2023. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Changzhou Waston Medical Appliance Co., Ltd. has at least 4 other 510(k) clearances on record.