# K231934: GIA™ Stapler with Tri-Staple™ Technology

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Oct 27, 2023 after 119 days
- Product code: GAG (Stapler, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K842066 (1985). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221006: GIA Stapler with Tri-Staple Technology, Covidien (2022) Summary page 5.

## 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/K231934
Methodology: https://510kreport.com/methodology