# K013860: Auto Suture Surgical Staples

- Pathway: 510(k) (Special)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Dec 19, 2001 after 28 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K855047 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K855047: Auto Suture Titanium Surgical Staples, United States Surgical, A Division of Tyco Healthc (1986) Summary page 1.

## Recalls of this device
- May 5, 2004 · Not classified · Z-0958-04: Stapler may clamp without the staples being fired into the tissue
- May 5, 2004 · Not classified · Z-0960-04: Stapler may clamp without the staples being fired into the tissue
- May 5, 2004 · Not classified · Z-0961-04: Stapler may clamp without the staples being fired into the tissue
- May 5, 2004 · Not classified · Z-0964-04: Stapler may clamp without the staples being fired into the tissue
- May 5, 2004 · Not classified · Z-0963-04: Stapler may clamp without the staples being fired into the tissue
- May 5, 2004 · Not classified · Z-0959-04: Stapler may clamp without the staples being fired into the tissue
- May 5, 2004 · Not classified · Z-0962-04: Stapler may clamp without the staples being fired into the tissue
- May 5, 2004 · Not classified · Z-0966-04: Stapler may clamp without the staples being fired into the tissue

## Indications for use
The Auto Suture Surgical Staples are intended to be used with the currently marketed Auto Suture TA Stapler and Single Use Loading Unit (SULU), Auto Suture GIA Stapler and SULU, and Auto Suture EEA Stapler and SULU.

Source page: https://510kreport.com/device/K013860
Methodology: https://510kreport.com/methodology