510(k) K100386

DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32 by Changzhou Waston Medical Appliance Co., Ltd. — Product Code GDW

K100386 is an FDA 510(k) premarket notification submitted by Changzhou Waston Medical Appliance Co., Ltd. for the device "DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32". The FDA issued a decision of Substantially Equivalent on March 1, 2010. 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.