# K202665: Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm

- Pathway: 510(k) (Special)
- Applicant: Ethicon Endo-Surgery, LLC
- Decided: Oct 15, 2020 after 31 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
Longest line of descent: 7 generations back to K051002 (2005). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163454: ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm, Ethicon Endo-Surgery, LLC (2017) Summary page 4.
- K160521: ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm, Ethicon Endo-Surgery, LLC (2016) Summary page 4.
- K140560: Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter, 60MM, Standard, Echelon Flex Powered Plus Articulating, Ethicon Endo-Surgery, LLC (2014) Summary page 4.

## Most influential descendants
- K254291: easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges (2026), 0 descendants of its own

## Recalls of this device
- Jun 3, 2021 · Class II · Z-2326-2021: Mislabeled: Labeled on the package as 60mm contains 45mm devices

## Indications for use
ECHELON, ECHELON ENDOPATH™ 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/K202665
Methodology: https://510kreport.com/methodology