# K151163: Signia Loading Unit, Tri-Staple 2.0 Cartridge

- Pathway: 510(k) (Special)
- Applicant: Covidien, LLC
- Decided: May 29, 2015 after 28 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)
- 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 4.
- K083519: Autosuture Endo Gia Staplers with Endo Gia Single Use Loading Units, Covidien Lp, Formerly Registered AS United States (2009) Summary page 4.

## Most influential descendants
- K163098: Tri-Staple 2.0 Intelligent Cartridge (2016), 0 descendants of its own

## Indications for use
The Signia Loading Units with Tri-Staple™ 2.0 cartridges 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 and transection and resection of pancreas.

Source page: https://510kreport.com/device/K151163
Methodology: https://510kreport.com/methodology