# 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

- Pathway: 510(k) (Traditional)
- Applicant: Ezisurg Medical Co., Ltd.
- Decided: Sep 25, 2026 after 268 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: 8 generations back to K051002 (2005). 31 ancestors in all.
No later device cites it as a predicate yet.
4 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Ethicon Endo-Surgery, LLC (2020) Summary page 6.
- K141952: Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon Vascular White Reloads for Advanced, Ethicon Endo-Surgery, Inc. (2014) Summary page 6.

## Indications for use
easyEndoTM E-Lite Single Use Powered Endoscopic Staplers are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general and thoracic surgical procedures. easyEndoTM E-Lite Single Use Powered Endoscopic Staplers with Curved Tip are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general and thoracic surgical procedures. easyEndoTM E-Lite Single Use Cartridges are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general and thoracic surgical procedures.

Source page: https://510kreport.com/device/K254291
Methodology: https://510kreport.com/methodology