# K221013: GIA Auto Suture Stapler with DST Series Technology

- Pathway: 510(k) (Special)
- Applicant: Covidien
- Decided: May 5, 2022 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: 11 generations back to K842066 (1985). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 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.

## Indications for use
The reloadable staplers have applications in abdominal and thoracic surgical procedures for resection, transection and creation of anastomosis.

Source page: https://510kreport.com/device/K221013
Methodology: https://510kreport.com/methodology
