# K080898: Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line Reinforcement

- Pathway: 510(k) (Traditional)
- Applicant: Tyco Healthcare Group LP
- Decided: May 5, 2008 after 35 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: 24 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K842066 (1985). 25 ancestors in all.
48 later devices descend from it; 4 cite it directly.
0 of 74 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.
- K000037: Monofilament Biosyn Suture, United States Surgical, A Division of Tyco Healthc (2000) Summary page 1.
- K043056: Gore Seamguard Bioabsorbable Staple Line Reinforcement Material, W. L. Gore & Associates, Inc. (2004) Summary page 1.
- K040119: Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line Reinforcement-Strip Configuration, Synovis Surgical Innovations (2004) 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

## Recalls of this device
- Aug 21, 2012 · Class II · Z-2436-2012: Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
- Aug 21, 2012 · Class II · Z-2439-2012: Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.
- Aug 21, 2012 · Class II · Z-2437-2012: Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
- Aug 21, 2012 · Class II · Z-2435-2012: Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
- Aug 21, 2012 · Class II · Z-2432-2012: Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
- Aug 21, 2012 · Class II · Z-2438-2012: Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
- Aug 21, 2012 · Class II · Z-2434-2012: Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.
- Aug 21, 2012 · Class II · Z-2433-2012: Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.
- Feb 16, 2012 · Not classified · Z-1227-2012: Missing component results in the stapler not firing.
- Jan 12, 2012 · Not classified · Z-0992-2012: Duet TRS Straight and Articulating Single Use (SULU)Loading Staplers used in thoracic surgery may result in serious injury or death
- Jan 12, 2012 · Not classified · Z-0993-2012: Duet TRS Straight and Articulating Single Use (SULU)Loading Staplers used in thoracic surgery may result in serious injury or death
- Jan 12, 2012 · Not classified · Z-0995-2012: Duet TRS Straight and Articulating Single Use (SULU)Loading Staplers used in thoracic surgery may result in serious injury or death
- Jan 12, 2012 · Not classified · Z-0991-2012: Duet TRS Straight and Articulating Single Use (SULU)Loading Staplers used in thoracic surgery may result in serious injury or death
- Jan 12, 2012 · Not classified · Z-0994-2012: Duet TRS Straight and Articulating Single Use (SULU)Loading Staplers used in thoracic surgery may result in serious injury or death
- Jan 12, 2012 · Not classified · Z-0996-2012: Duet TRS Straight and Articulating Single Use (SULU)Loading Staplers used in thoracic surgery may result in serious injury or death
- Jan 12, 2012 · Not classified · Z-0998-2012: Duet TRS Straight and Articulating Single Use (SULU)Loading Staplers used in thoracic surgery may result in serious injury or death
- Aug 15, 2011 · Not classified · Z-3167-2011: Sterility of the device is compromised due to a breach in the sterile packaging
- Aug 15, 2011 · Not classified · Z-3169-2011: Sterility of the device is compromised due to a breach in the sterile packaging
- Aug 15, 2011 · Not classified · Z-3170-2011: Sterility of the device is compromised due to a breach in the sterile packaging
- Aug 15, 2011 · Not classified · Z-3165-2011: Sterility of the device is compromised due to a breach in the sterile packaging
- Aug 15, 2011 · Not classified · Z-3171-2011: Sterility of the device is compromised due to a breach in the sterile packaging
- Aug 15, 2011 · Not classified · Z-3168-2011: Sterility of the device is compromised due to a breach in the sterile packaging
- Aug 15, 2011 · Not classified · Z-3166-2011: Sterility of the device is compromised due to a breach in the sterile packaging
- Aug 15, 2011 · Not classified · Z-3164-2011: Sterility of the device is compromised due to a breach in the sterile packaging

## Indications for use
The Autosuture TM ENDO GIA T M Staplers with ENDO GIA TM Single Use Loading Units with Staple Line Reinforcement 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/K080898
Methodology: https://510kreport.com/methodology