# K173270: Tri-Staple 2.0 Reinforced Reload

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Feb 20, 2018 after 131 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K842066 (1985). 67 ancestors in all.
No later device cites it as a predicate yet.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133938: Endo Gia Reinforced Reload with Tri-Staple Technology, Covidien (2014) Summary page 4.

## Recalls of this device
- Apr 15, 2024 · Class II · Z-1891-2024: Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery
- Mar 23, 2021 · Class II · Z-1419-2021: Potential for the pouch to contain an extra laminate layer, creating the potential for the device sterility to be compromised. The inclusion of an additional laminate layer in the package may also imp

## Indications for use
The Tri-Staple 2.0 Reinforced Reload preloaded with polyglycolic acid staple line reinforcement has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis. 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/K173270
Methodology: https://510kreport.com/methodology