# K241630: ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T)

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, LLC
- Decided: Oct 28, 2024 after 144 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K051002 (2005). 13 ancestors in all.
No later device cites it as a predicate yet.
3 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213633: ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler, Ethicon Endo-Surgery, LLC (2022) Summary page 5.
- K183435: Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black, Ethicon Endo-Surgery, LLC (2019) Summary page 5.

## Indications for use
The ETHICON™ 4000 Staplers and ETHICON™ 3D Reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue reinforcement materials.

Source page: https://510kreport.com/device/K241630
Methodology: https://510kreport.com/methodology