# K221006: GIA Stapler with Tri-Staple Technology

- Pathway: 510(k) (Special)
- Applicant: Covidien
- Decided: Apr 29, 2022 after 24 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). 45 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202701: GIA Stapler with Tri-Staple Technology, Covidien (2020) Summary page 4.
- K192720: GIA Stapler with Tri-Staple Technology, Covidien (2020) Summary page 4.

## Most influential descendants
- K231934: GIA™ Stapler with Tri-Staple™ Technology (2023), 0 descendants of its own

## Indications for use
The GIA™ stapler with Tri‑Staple™ technology has applications in abdominal and thoracic surgical procedures for resection, transection and creation of anastomosis.

Source page: https://510kreport.com/device/K221006
Methodology: https://510kreport.com/methodology