# K111825: Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM) Staplers

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, Formerly US Surgical A Divison of Tyco H
- Decided: Oct 25, 2011 after 119 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: 73 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K842066 (1985). 42 ancestors in all.
44 later devices descend from it; 22 cite it directly.
0 of 87 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.
- K083519: Autosuture Endo Gia Staplers with Endo Gia Single Use Loading Units, Covidien Lp, Formerly Registered AS United States (2009) Summary page 1.
- K093410: Autosuture Endo Gia Single Use Black Reload with Tri-Staple Technology, Surgical Devices, A Divsion of Tyco Healthcare (2009) Summary page 1.
- K101444: Autosuture Endo Gia Single Use Tan Reload with Tri-Staple Technology, Surgical Devices, A Global Business Unit Tyco (2010) Summary page 1.
- K103263: Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE Technology, Covidien, Formerly US Surgical A Divison of Tyco H (2010) Summary page 1.
- K102291: Covidien Endo Gia Radial Reload with Tri-Staple Technology, Covidien (2010) Summary page 1.
- K080898: Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line Reinforcement, Tyco Healthcare Group LP (2008) Summary page 1.
- K032696: Auto Suture Endoscopic (& Open) TA Surgical Stapler, Auto Suture Endoscopic (& Open) Gia Surgical Stapling Instrument, United States Surgical, A Division of Tyco Healthc (2003) Summary page 1.
- K070887: Endopath Linear Cutters and Staplers and ECHELON60 Endoscopic Linear Cutters and Staplers (and Reloads), Ethicon Endo-Surgery, LLC (2007) Summary page 1.

## Most influential descendants
- 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
- K161757: Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and Reloads, Single Use Endoscopic Linear Cutters and Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers and Reloads (2016), 3 descendants of its own
- K132581: Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple Cartridge, Blue Staple Cartridge (2014), 3 descendants of its own

## Recalls of this device
- Nov 23, 2020 · Class II · Z-0747-2021: May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line preventing adequate hemostasis, or leading to a
- Nov 23, 2020 · Class II · Z-0748-2021: May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line preventing adequate hemostasis, or leading to a
- Aug 12, 2020 · Class II · Z-0001-2021: The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
- Aug 12, 2020 · Class II · Z-0005-2021: The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
- Aug 12, 2020 · Class II · Z-0004-2021: The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
- Aug 12, 2020 · Class II · Z-0002-2021: The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
- Aug 12, 2020 · Class II · Z-0008-2021: The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
- Aug 12, 2020 · Class II · Z-0007-2021: The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
- Aug 12, 2020 · Class II · Z-0009-2021: The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
- Aug 12, 2020 · Class II · Z-0006-2021: The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
- Aug 12, 2020 · Class II · Z-0003-2021: The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
- Jan 17, 2020 · Class II · Z-1264-2020: Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection
- May 17, 2019 · Class II · Z-1829-2019: The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or p
- May 17, 2019 · Class II · Z-1831-2019: The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or p
- May 17, 2019 · Class II · Z-1834-2019: The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or p
- May 17, 2019 · Class II · Z-1833-2019: The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or p
- May 17, 2019 · Class II · Z-1836-2019: The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or p
- May 17, 2019 · Class II · Z-1825-2019: The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or p
- May 17, 2019 · Class II · Z-1832-2019: The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or p
- May 17, 2019 · Class II · Z-1830-2019: The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or p
- May 17, 2019 · Class II · Z-1827-2019: The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or p
- May 17, 2019 · Class II · Z-1835-2019: The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or p
- May 17, 2019 · Class II · Z-1826-2019: The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or p
- May 17, 2019 · Class II · Z-1828-2019: The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or p
- May 22, 2018 · Class II · Z-2503-2018: Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage
- May 22, 2018 · Class II · Z-2505-2018: Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage
- May 22, 2018 · Class II · Z-2504-2018: Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage
- Apr 26, 2018 · Class II · Z-1855-2018: Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage
- Apr 26, 2018 · Class II · Z-1866-2018: Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage
- Apr 26, 2018 · Class II · Z-1826-2018: Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage
- Apr 26, 2018 · Class II · Z-1840-2018: Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage
- Apr 26, 2018 · Class II · Z-1824-2018: Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage
- Apr 26, 2018 · Class II · Z-1844-2018: Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage
- Apr 26, 2018 · Class II · Z-1859-2018: Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage
- Apr 26, 2018 · Class II · Z-1837-2018: Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage
- Apr 26, 2018 · Class II · Z-1833-2018: Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage
- Apr 26, 2018 · Class II · Z-1852-2018: Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage
- Apr 26, 2018 · Class II · Z-1828-2018: Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage
- Apr 26, 2018 · Class II · Z-1842-2018: Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage
- Apr 26, 2018 · Class II · Z-1822-2018: Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage
- Apr 26, 2018 · Class II · Z-1817-2018: Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage
- Apr 26, 2018 · Class II · Z-1831-2018: Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage
- Apr 26, 2018 · Class II · Z-1843-2018: Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage
- Apr 26, 2018 · Class II · Z-1863-2018: Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage
- Apr 26, 2018 · Class II · Z-1815-2018: Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage
- Apr 26, 2018 · Class II · Z-1849-2018: Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage
- Apr 26, 2018 · Class II · Z-1814-2018: Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage
- Apr 26, 2018 · Class II · Z-1839-2018: Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage
- Apr 26, 2018 · Class II · Z-1850-2018: Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage
- Apr 26, 2018 · Class II · Z-1865-2018: Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage

## Indications for use
Endo GIA TM Staplers: The following indications are applicable to the Endo GIA TM Ultra Universal Stapler with Endo GIA TM Reloads with Tni-Staple TM Technology including Curved Tip Reloads: The Endo GIA TM Ultra Universal Staplers 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 and for transection and resection of pancreas. The Endo GIA TM Ultra Universal Staplers when used with the Endo GIA TM Curved-Tip Reloads can be used to blunt dissect or separate target tissue from other certain tissue. The following indications are applicable to the Endo GIA TM Ultra Universal Stapler with Duet TRS TM Reloads with Tni-Staple TM Technology including Duet TRS TM Curved Tip Reloads: The Endo GIA TM Ultra Universal Staplers with Duet TRS TM Reloads with Tni-Staple TM Technology 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 and for transection and resection of pancreas. The Endo GIA TM Ultra Universal Staplers when used with the Duet TRS TM Curved-Tip Reloads can be used to blunt dissect or separate target tissue from other certain tissue. The following indications are applicable to the Endo GIA TM Ultra Universal Stapler with Radial Reload with Tri-Staple TM Technology: The Endo GIA TM Radial Reload with Tni-Staple TM Technology has application in open or minimally invasive general abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, i.e. low anterior resection. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas. The following indications are applicable to the Endo GIA TM Universal Stapler with Endo GIA TM Straight and Roticulator TM SULUs: The Endo GIA TM Universal Staplers 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 and for transection and resection of pancreas. The following indications are applicable to the Endo GIA TM Universal Stapler with Duet TRS TM Reloads: The Endo GIA TM Ultra Universal Staplers with Duet TRS TM 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 and for transection and resection of pancreas. DST Series GIA TM: The Auto Suture GIA TM Reloadable Staplers and the SGIA TM Knifeless Stapler have applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis. The SGIA TM Knifeless stapler may be used for occlusion of the left atrial appendage in open procedures. They may be used for transection and resection of pancreas. DST Series TA TM: The Auto Suture TA TM Reloadable staplers have applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue and creation of anastomosis, including occlusion of the left atrial appendage in open procedures. They may be used for transection and resection of pancreas.

Source page: https://510kreport.com/device/K111825
Methodology: https://510kreport.com/methodology