# K140560: Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter, 60MM, Standard, Echelon Flex Powered Plus Articulating

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, LLC
- Decided: Apr 22, 2014 after 48 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K051002 (2005). 8 ancestors in all.
19 later devices descend from it; 7 cite it directly.
6 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130653: Echelon Flex 45 Powered Articulating Endoscopic Linear Cutter; Echelon Flex 60 Powered Articulating Endoscopic Linear CU, Ethicon Endo-Surgery, LLC (2013) Summary page 1.
- K110385: Echelon Flex 45 / 60 Powered Articulating Endoscopic Linear Cutter, Ethicon Endo-Surgery, Inc. (2011)
- K121600: Echelon 60 Endoscpic Linear Cutter Reload, White, Ethicon Endo-Surgery, LLC (2012) 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.
- K051002: Endopath Endocutter 60 Endoscopic Linear Cutter, Ethicon Endo-Surgery, Inc. (2005) Summary page 1.
- K131663: Echelon Endoscopic Linear Cutter Reload, Black, Ethicon Endo-Surgery, LLC (2013) Summary page 1.
- K112056: Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T, Echelon 45 Endoscopic Linear Cutter Reload, Black Model, Ethicon Endo-Surgery, LLC (2011) Summary page 2.

## Most influential descendants
- 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
- K213633: ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler (2022), 5 descendants of its own
- K183224: SureForm 45, SureForm 45 Reloads (2019), 5 descendants of its own

## Recalls of this device
- Oct 3, 2019 · Class I · Z-0202-2020: 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
- Oct 3, 2019 · Class I · Z-0203-2020: 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 ENDOPATH ECHELON" and ECHELON FLEX" families of endoscopic linear cutters and reloads 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/K140560
Methodology: https://510kreport.com/methodology