510(k) K080898

AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STAPLE LINE REINFORCEMENT by Tyco Healthcare Group LP — Product Code GDW

K080898 is an FDA 510(k) premarket notification submitted by Tyco Healthcare Group LP for the device "AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STAPLE LINE REINFORCEMENT". The FDA issued a decision of Substantially Equivalent on May 5, 2008. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Tyco Healthcare Group LP has at least 5 other 510(k) clearances on record.