# K202864: Tri-Staple 2.0 Reloads

- Pathway: 510(k) (Special)
- Applicant: Covidien
- Decided: Oct 28, 2020 after 30 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). 74 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160176: Signia Stapler, Covidien (2016) Summary page 4.

## Most influential descendants
- K253657: Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter Reloads (2026), 0 descendants of its own

## Indications for use
The Tri-Staplem 2.0 reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of pancreas. The Tri-StapleTm 2.0 curved tip reloads can be used to blunt dissect or separate target tissue from other tissue.

Source page: https://510kreport.com/device/K202864
Methodology: https://510kreport.com/methodology