Clearance Summary
ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L) received FDA 510(k) clearance under submission number K241629, sponsored by Ethicon Endo-Surgery, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2024-07-03.
- Submission: K241629
- Applicant / Sponsor: Ethicon Endo-Surgery, LLC
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 878.4740
- Decision date: 2024-07-03
Classification & Regulation
This clearance is catalogued under FDA product code GAG and 21 CFR 878.4740, within the General Hospital review panel as a Class II device.