510(k) K172538

Disposable Linear Stapler, Disposable Linear Cutter by Changzhou Kangdi Medical Stapler Co., Ltd. — Product Code GDW

K172538 is an FDA 510(k) premarket notification submitted by Changzhou Kangdi Medical Stapler Co., Ltd. for the device "Disposable Linear Stapler, Disposable Linear Cutter". The FDA issued a decision of Substantially Equivalent on Nov 30, 2017. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Changzhou Kangdi Medical Stapler Co., Ltd. has 3 other 510(k) clearances on record.