# K103263: Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE Technology

- Pathway: 510(k) (Special)
- Applicant: Covidien, Formerly US Surgical A Divison of Tyco H
- Decided: Nov 22, 2010 after 18 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: 9 generations back to K842066 (1985). 32 ancestors in all.
45 later devices descend from it; 2 cite it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083519: Autosuture Endo Gia Staplers with Endo Gia Single Use Loading Units, Covidien Lp, Formerly Registered AS United States (2009) 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.
- K080898: Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line Reinforcement, Tyco Healthcare Group LP (2008) Summary page 1.
- K090419: Sils Stitch Endoscopic Suturing Device, Covidien Lp, Formerly Registered AS United States (2009) Summary page 1.

## Most influential descendants
- K111825: Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM) Staplers (2011), 44 descendants of its own
- K121510: Idrive Ultra Powered Handle Endo Gia Adapter (2012), 8 descendants of its own
- K160176: Signia Stapler (2016), 5 descendants of its own
- K192720: GIA Stapler with Tri-Staple Technology (2020), 3 descendants of its own
- K161757: Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and Reloads, Single Use Endoscopic Linear Cutters and Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers and Reloads (2016), 3 descendants of its own

## Indications for use
The Endo GIA™ Staplers with Endo GIA™ Single Use Duet TRS™ Reloads with Tri-Staple™ Technology have 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.

Source page: https://510kreport.com/device/K103263
Methodology: https://510kreport.com/methodology