# K080839: Echelon Gray Cartridge, Model ERC45M

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, LLC
- Decided: May 21, 2008 after 57 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: 1 generation back to K033269 (2003). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033269: Endopath Endocutter Gray Cartridge, Model 6R45M/Gray Cartridge Reload, Ethicon Endo-Surgery, Inc. (2003) Summary page 1.
- K051002: Endopath Endocutter 60 Endoscopic Linear Cutter, Ethicon Endo-Surgery, Inc. (2005) Summary page 1.
- K070887: Endopath Linear Cutters and Staplers and ECHELON60 Endoscopic Linear Cutters and Staplers (and Reloads), Ethicon Endo-Surgery, LLC (2007) Summary page 1.

## Most influential descendants
- K210909: easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use (2021), 0 descendants of its own

## Indications for use
The Echelon Endoscopic Cutters, Staplers and Reloads are intended for transection, resection, and/or anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.

Source page: https://510kreport.com/device/K080839
Methodology: https://510kreport.com/methodology