510(k) K061095

AUTO SUTUR ENDO GIA STAPLERS by United States Surgical, A Division of Tyco Healthc — Product Code GDW

K061095 is an FDA 510(k) premarket notification submitted by United States Surgical, A Division of Tyco Healthc for the device "AUTO SUTUR ENDO GIA STAPLERS". The FDA issued a decision of Substantially Equivalent on May 31, 2006. 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.