# K110385: Echelon Flex 45 / 60 Powered Articulating Endoscopic Linear Cutter

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Mar 25, 2011 after 43 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: 2 generations back to K051002 (2005). 3 ancestors in all.
27 later devices descend from it; 3 cite it directly.
7 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081146: Echelon Endoscopic Linear Cutters (Articulating and Straight), Ethicon Endo-Surgery, LLC (2008)

## Most influential descendants
- K130653: Echelon Flex 45 Powered Articulating Endoscopic Linear Cutter; Echelon Flex 60 Powered Articulating Endoscopic Linear CU (2013), 23 descendants of its own
- K140560: Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter, 60MM, Standard, Echelon Flex Powered Plus Articulating (2014), 19 descendants of its own
- K160521: ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm (2016), 9 descendants of its own
- K163454: ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm (2017), 8 descendants of its own
- K173721: SureForm 60 and SureForm 60 Reloads (2018), 6 descendants of its own

## Indications for use
The ECHELON families of endoscopic linear cutters 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/K110385
Methodology: https://510kreport.com/methodology