510(k) K201280

Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed by Ethicon Endo-Surgery, LLC — Product Code GDW

K201280 is an FDA 510(k) premarket notification submitted by Ethicon Endo-Surgery, LLC for the device "Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed". The FDA issued a decision of Substantially Equivalent on July 27, 2020. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Ethicon Endo-Surgery, LLC has at least 10 other 510(k) clearances on record.