# K163098: Tri-Staple 2.0 Intelligent Cartridge

- Pathway: 510(k) (Special)
- Applicant: Covidien, LLC
- Decided: Dec 5, 2016 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: 13 generations back to K842066 (1985). 75 ancestors in all.
No later device cites it as a predicate yet.
0 of 76 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.
- K151163: Signia Loading Unit, Tri-Staple 2.0 Cartridge, Covidien, LLC (2015) Summary page 4.
- K160176: Signia Stapler, Covidien (2016) Summary page 4.
- (no number) Endo GIA™ Gray Articulating Reload: named in the summary without a submission number
- (no number) Endo GIA™ AutoSuture™ Universal Articulating Loading Unit: named in the summary without a submission number

## Indications for use
The Signia™ intelligent loading units-and Tri-Staple™ 2.0 intelligent cartridges have applications in abdominal, gynesologic, pediatric and thoracic surgery for rescction, transection and ercation of anastomosis. They may be used for transection and sesection of liver substance, hepatic vaseulature and biliary structures, and for transection and resection of PANLTEAS,

Source page: https://510kreport.com/device/K163098
Methodology: https://510kreport.com/methodology