510(k) K241629
K241629 is an FDA 510(k) premarket notification submitted by Ethicon Endo-Surgery, LLC for the device "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)". The FDA issued a decision of Substantially Equivalent on July 3, 2024. The device falls under product code GAG (Stapler, Surgical), a Class II device regulated under 21 CFR 878.4740. Ethicon Endo-Surgery, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 3, 2024
- Date Received
- June 6, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stapler, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4740
- Review Panel
- SU
- Submission Type
A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.