Clearance Summary
Echelon Endopath Staple Line Reinforcement received FDA 510(k) clearance under submission number K190937, 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 2019-10-14.
- Submission: K190937
- 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: 2019-10-14
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.