# K093410: Autosuture Endo Gia Single Use Black Reload with Tri-Staple Technology

- Pathway: 510(k) (Special)
- Applicant: Surgical Devices, A Divsion of Tyco Healthcare
- Decided: Nov 12, 2009 after 10 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: 2 generations back to K061095 (2006). 2 ancestors in all.
46 later devices descend from it; 3 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083519: Autosuture Endo Gia Staplers with Endo Gia Single Use Loading Units, Covidien Lp, Formerly Registered AS United States (2009) Summary page 1.
- K061095: Auto Sutur Endo Gia Staplers, United States Surgical, A Division of Tyco Healthc (2006) Summary page 1.

## Most influential descendants
- K103263: Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE Technology (2010), 45 descendants of its own
- K111825: Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM) Staplers (2011), 44 descendants of its own
- K121510: Idrive Ultra Powered Handle Endo Gia Adapter (2012), 8 descendants of its own
- K160176: Signia Stapler (2016), 5 descendants of its own
- K192720: GIA Stapler with Tri-Staple Technology (2020), 3 descendants of its own

## Indications for use
The AutosutureTM Endo GIA TM Staplers with Endo GIATM Single Use Reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.

Source page: https://510kreport.com/device/K093410
Methodology: https://510kreport.com/methodology