# K120258: Duet TRS Reloads, Duet TRS Reloads with Tri-Staple Technology, Endo Gia Universal and Ultra Universal Staplers

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, Formerly US Surgical A Divison of Tyco H
- Decided: Feb 29, 2012 after 33 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.
1 later device descends from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- 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.
- K103263: Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE Technology, Covidien, Formerly US Surgical A Divison of Tyco H (2010) Summary page 1.

## Most influential descendants
- K143129: easyEndo Linear Cutting Stapler and Loading Unit for Single Use (Stapler;Loading Unit) (2015), 0 descendants of its own

## Indications for use
The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas The Duet TRS Reloads with Tn-Staple Technology have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. 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/K120258
Methodology: https://510kreport.com/methodology