About This 510(k) Submission
K252906 is an FDA 510(k) clearance for the ECHELON ENDOPATH Staple Line Reinforcement (ECH60R), a Mesh, Surgical, Absorbable, Staple Line Reinforcement (Class II — Special Controls, product code OXC), submitted by Ethicon Endo-Surgery, LLC (Guaynabo, US). The FDA issued a Cleared decision on January 9, 2026, 119 days after receiving the submission on September 12, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.