510(k) K121474

DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER by Changzhou Kangdi Medical Stapler Co., Ltd. — Product Code GDW

K121474 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 Jul 16, 2012. 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.