# K081146: Echelon Endoscopic Linear Cutters (Articulating and Straight)

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, LLC
- Decided: Jun 26, 2008 after 65 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K051002 (2005). 2 ancestors in all.
50 later devices descend from it; 6 cite it directly.
7 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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
- K110385: Echelon Flex 45 / 60 Powered Articulating Endoscopic Linear Cutter (2011), 27 descendants of its own
- K112056: Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T, Echelon 45 Endoscopic Linear Cutter Reload, Black Model (2011), 25 descendants of its own
- K130653: Echelon Flex 45 Powered Articulating Endoscopic Linear Cutter; Echelon Flex 60 Powered Articulating Endoscopic Linear CU (2013), 23 descendants of its own
- K121600: Echelon 60 Endoscpic Linear Cutter Reload, White (2012), 23 descendants of its own
- K131663: Echelon Endoscopic Linear Cutter Reload, Black (2013), 20 descendants of its own

## Recalls of this device
- Oct 3, 2019 · Class I · Z-0200-2020: The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple l

## Indications for use
The Echelon families of endoscopic linear cutters (articulating and straight) are intended for transection, resection, and/or creation of 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/K081146
Methodology: https://510kreport.com/methodology