About This 510(k) Submission
K243276 is an FDA 510(k) clearance for the ECHELON LINEAR? Stapler 30mm Stapler (GTX30); ECHELON LINEAR? Stapler 60mm Stapler (GTX60); ECHELON LINEAR? Stapler 90mm Stapler (GTX90); ECHELON LINEAR? Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR? Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR? Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR? Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR? Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR? Stapler 3D 90mm Green Reload (GTXR90G), a Staple, Implantable (Class II — Special Controls, product code GDW), submitted by Ethicon Endo-Surgery, LLC (Guaynabo, US). The FDA issued a Cleared decision on February 25, 2025, 132 days after receiving the submission on October 16, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4750.