510(k) K221005

EEA Circular Stapler with Tri-Staple Technology by Covidien — Product Code GDW

K221005 is an FDA 510(k) premarket notification submitted by Covidien for the device "EEA Circular Stapler with Tri-Staple Technology". The FDA issued a decision of Substantially Equivalent on April 29, 2022. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Covidien has at least 10 other 510(k) clearances on record.