510(k) K100723

DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CIRCULAR STAPLER MODEL KYGW-25.5, KYGW-28.5 by Changzhou Kangdi Medical Stapler Co., Ltd. — Product Code GDW

K100723 is an FDA 510(k) premarket notification submitted by Changzhou Kangdi Medical Stapler Co., Ltd. for the device "DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CIRCULAR STAPLER MODEL KYGW-25.5, KYGW-28.5". The FDA issued a decision of Substantially Equivalent on Apr 30, 2010. 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.