# K855047: Auto Suture Titanium Surgical Staples

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Jan 14, 1986 after 28 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K093253: Amid Stapler (2009), 1 descendant of its own
- K120268: Amid Stapler (2012), 0 descendants of its own
- K013860: Auto Suture Surgical Staples (2001), 0 descendants of its own

## Recalls of this device
- May 9, 2012 · Class II · Z-1844-2012: Potential for the sterility barrier to be compromised.
- May 9, 2012 · Class II · Z-1847-2012: Potential for the sterility barrier to be compromised.
- May 9, 2012 · Class II · Z-1846-2012: Potential for the sterility barrier to be compromised.
- May 9, 2012 · Class II · Z-1848-2012: Potential for the sterility barrier to be compromised.
- May 9, 2012 · Class II · Z-1845-2012: Potential for the sterility barrier to be compromised.

Source page: https://510kreport.com/device/K855047
Methodology: https://510kreport.com/methodology