# K210909: easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Ezisurg Medical Co., Ltd.
- Decided: Jun 24, 2021 after 87 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: 12 generations back to K842066 (1985). 47 ancestors in all.
No later device cites it as a predicate yet.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172960: easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use, Ezisurg Medical Co., Ltd. (2017) Summary page 5.
- K080839: Echelon Gray Cartridge, Model ERC45M, Ethicon Endo-Surgery, LLC (2008) Summary page 5.

## Indications for use
The easyEndoTM Lite Linear Cutting Stapler and Loading Units for Single Use are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.

Source page: https://510kreport.com/device/K210909
Methodology: https://510kreport.com/methodology