510(k) K013860

AUTO SUTURE SURGICAL STAPLES by United States Surgical, A Division of Tyco Healthc — Product Code GDW

K013860 is an FDA 510(k) premarket notification submitted by United States Surgical, A Division of Tyco Healthc for the device "AUTO SUTURE SURGICAL STAPLES". The FDA issued a decision of Substantially Equivalent on December 19, 2001. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. United States Surgical, A Division of Tyco Healthc has at least 10 other 510(k) clearances on record.