# K061095: Auto Sutur Endo Gia Staplers

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: May 31, 2006 after 42 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
No predicates in its family tree.
55 later devices descend from it; 7 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Auto Suture ENDO GIA Stapler: named in the summary without a submission number

## Most influential descendants
- K083519: Autosuture Endo Gia Staplers with Endo Gia Single Use Loading Units (2009), 49 descendants of its own
- K080898: Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line Reinforcement (2008), 48 descendants of its own
- K101444: Autosuture Endo Gia Single Use Tan Reload with Tri-Staple Technology (2010), 46 descendants of its own
- K093410: Autosuture Endo Gia Single Use Black Reload with Tri-Staple Technology (2009), 46 descendants of its own
- K103263: Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE Technology (2010), 45 descendants of its own

## Indications for use
The Auto Suture ENDO GIA Staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomoses. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.

Source page: https://510kreport.com/device/K061095
Methodology: https://510kreport.com/methodology