# K083519: Autosuture Endo Gia Staplers with Endo Gia Single Use Loading Units

- Pathway: 510(k) (Traditional)
- Applicant: Covidien Lp, Formerly Registered AS United States
- Decided: Apr 10, 2009 after 135 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: 1 generation back to K061095 (2006). 1 ancestor in all.
49 later devices descend from it; 6 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061095: Auto Sutur Endo Gia Staplers, United States Surgical, A Division of Tyco Healthc (2006) Summary page 1.

## Most influential descendants
- 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
- K102291: Covidien Endo Gia Radial Reload with Tri-Staple 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

## Indications for use
The Autosuture ENDO GIA Staplers with ENDO GIA Single Use Loading Units (SULUs) 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. The Autosuture ENDO GIA Staplers when used with the ENDO GIA Curved-Tip Single Use Loading Unit (SULUs) can be used to blunt dissect or separate target tissue from other certain tissue.

Source page: https://510kreport.com/device/K083519
Methodology: https://510kreport.com/methodology