# K132493: Endo Gia Radial Reload with Tri-Staple Technology

- Pathway: 510(k) (Special)
- Applicant: Covidien, LLC
- Decided: Oct 23, 2013 after 75 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: 12 generations back to K842066 (1985). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131705: Endo Gia Radial Reload with Tri-Staple Technology, Covidien, Formerly US Surgical A Divison of Tyco H (2013) Summary page 1.
- K093410: Autosuture Endo Gia Single Use Black Reload with Tri-Staple Technology, Surgical Devices, A Divsion of Tyco Healthcare (2009) Summary page 1.
- K101444: Autosuture Endo Gia Single Use Tan Reload with Tri-Staple Technology, Surgical Devices, A Global Business Unit Tyco (2010) Summary page 1.

## Recalls of this device
- Sep 15, 2017 · Class II · Z-0908-2018: The device cartridge disengaged during use due to manufacturing error.

## Indications for use
The Endo GIA Radial Reload with Tri-Staple Technology has application in open or minimally invasive general abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, i.e. low anterior resection. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

Source page: https://510kreport.com/device/K132493
Methodology: https://510kreport.com/methodology