Clearance Summary
ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) received FDA 510(k) clearance under submission number K252906, sponsored by Ethicon Endo-Surgery, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2026-01-09.
- Submission: K252906
- Applicant / Sponsor: Ethicon Endo-Surgery, LLC
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2026-01-09
Classification & Regulation
This clearance is catalogued under FDA product code OXC and 21 CFR 878.3300, within the General, Plastic Surgery review panel as a Class II device.