# K223760: ECHELON LINEAR™ 60 mm Cutter  (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™ 100 mm Cutter (GLC100);ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR™ Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G)

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery
- Decided: Mar 15, 2023 after 90 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K821994 (1982). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020779: Proximate and Endopath Linear Cutters and Staplers, Ethicon Endo-Surgery, Inc. (2002) Summary page 4.

## Recalls of this device
- Sep 11, 2025 · Class II · Z-0147-2026: The devices were shipped unsterilized.

## Indications for use
The ECHELON LINEAR™ Cutters have application in gastrointestinal, thoracic, and pediatric surgery for transection, resection, and the creation of anastomoses.

Source page: https://510kreport.com/device/K223760
Methodology: https://510kreport.com/methodology