# K130717: Endo Gia Reload

- Pathway: 510(k) (Special)
- Applicant: Covidien, Formerly US Surgical A Divison of Tyco H
- Decided: Apr 18, 2013 after 34 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: 11 generations back to K842066 (1985). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061095: Auto Sutur Endo Gia Staplers, United States Surgical, A Division of Tyco Healthc (2006) Summary page 2.
- K111825: Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM) Staplers, Covidien, Formerly US Surgical A Divison of Tyco H (2011) Summary page 1.

## Indications for use
The Endo GIA TM Reload has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They 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/K130717
Methodology: https://510kreport.com/methodology