K252906 is an FDA 510(k) clearance for the ECHELON ENDOPATH Staple Line Reinforcement (ECH60R). This device is classified as 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 FDA review panel. Regulated under 21 CFR 878.3300. For Reinforcement Of Soft Tissue Where Weakness Exists During Staple Line Reinforcement Procedures..
| 510(k) Number | K252906 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2025 |
| Decision Date | January 09, 2026 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OXC — Mesh, Surgical, Absorbable, Staple Line Reinforcement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |
| Definition | For Reinforcement Of Soft Tissue Where Weakness Exists During Staple Line Reinforcement Procedures. |