# K051002: Endopath Endocutter 60 Endoscopic Linear Cutter

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: May 17, 2005 after 27 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
54 later devices descend from it; 6 cite it directly.
7 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ENDOPATH® Linear Cutters and Staplers: named in the summary without a submission number

## Most influential descendants
- K081146: Echelon Endoscopic Linear Cutters (Articulating and Straight) (2008), 50 descendants of its own
- 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

## Recalls of this device
- Mar 2, 2012 · Not classified · Z-1627-2012: There is a possibility of a component breakage, which may cause the device to stay locked on tissue after firing. If the component exhibits this issue, the device does not open either with the anvil r

## Indications for use
The ENDOPATH Endocutter 60 Endoscopic Linear Cutter is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. It can be used with staple line or'tissue buttressing materials.

Source page: https://510kreport.com/device/K051002
Methodology: https://510kreport.com/methodology