# K163454: ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm

- Pathway: 510(k) (Special)
- Applicant: Ethicon Endo-Surgery, LLC
- Decided: Jan 5, 2017 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
Longest line of descent: 6 generations back to K051002 (2005). 10 ancestors in all.
8 later devices descend from it; 2 cite it directly.
3 of 19 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K213633: ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler (2022), 5 descendants of its own
- K241629: ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler  (ECH45S); Echelon 3000 45mm Long Stapler  (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler  (ECH60S); Echelon 3000 60mm Long Stapler  (ECH60L) (2024), 3 descendants of its own
- K250835: ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T) (2025), 1 descendant of its own
- 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 (2020), 1 descendant of its own
- 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
- Dec 11, 2023 · Class II · Z-0834-2024: There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical interv

## 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/K163454
Methodology: https://510kreport.com/methodology