# K121600: Echelon 60 Endoscpic Linear Cutter Reload, White

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, LLC
- Decided: Jul 16, 2012 after 45 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: 3 generations back to K051002 (2005). 4 ancestors in all.
23 later devices descend from it; 2 cite it directly.
7 of 28 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) 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)
- 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 1.

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

## Indications for use
The ECHELON families of endoscopic linear cutters are intended for transection, resection, and/or creation of anastomnoses. 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 parenchymna (hepatic vasculature and biliary structures), pancreas, kidney and spleen.

Source page: https://510kreport.com/device/K121600
Methodology: https://510kreport.com/methodology