# K160176: Signia Stapler - Pathway: 510(k) (Traditional) - Applicant: Covidien - Decided: Apr 26, 2016 after 90 days - Product code: GDW (Staple, Implantable) - Device class: 2 - Regulation: 21 CFR 878.4750 - Recalls of this device: 14 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 12 generations back to K842066 (1985). 73 ancestors in all. 5 later devices descend from it; 4 cite it directly. 0 of 79 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K121510: Idrive Ultra Powered Handle Endo Gia Adapter, Covidien, Formerly US Surgical A Divison of Tyco H (2012) Summary page 4. ## Most influential descendants - K202864: Tri-Staple 2.0 Reloads (2020), 1 descendant of its own - K253657: Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter Reloads (2026), 0 descendants of its own - K201672: Signia Stapler (with new software) (2020), 0 descendants of its own - K170348: Signia Four-Bay Smart Charger (to be used with Signia Stapler) (2017), 0 descendants of its own - K163098: Tri-Staple 2.0 Intelligent Cartridge (2016), 0 descendants of its own ## Recalls of this device - Jan 25, 2023 · Class II · Z-1228-2023: Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and tissue han - 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 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-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-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-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-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-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-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-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-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-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 - Dec 13, 2017 · Class II · Z-1237-2018: Product reportedly shutting down during use. ## Indications for use The Signia™ Stapler, when used with Endo GIA™ single-use reloads, Endo GIA™ single-use reloads with Tri-Staple™ Technology, Tri-Staple™ 2.0 single-use reloads and Signia™ loading units with Tri-Staple™ 2.0 single-use cartridges, has applications in abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis. it may be used for transection and resection of liver substance, hepatic vasculature, and biliary structures and for transection and resection of the pancreas. The Signia™ Stapler, when used with Endo GIA™ curved tip single use reloads or Tri-Staple™ 2.0 curved tip single-use reloads, can be used to blunt dissect or separate target tissue from other certain tissue. The Signia™ Stapler, when used with Endo GIA™ singie use Radial Reloads with Tri-Staple™ Technology, has applications 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 the pancreas. The Signia™ Stapler, when used with Endo GIA™ single use reinforced reloads with Tri-Staple™ Technology preloaded with polyglycolic acid staple line reinforcement or Tri-Staple™ 2.0 single use reinforced reloads preloaded with polyglycolic acid staple line reinforcement, has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis. it may be used for transection and resection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of the pancreas. Source page: https://510kreport.com/device/K160176 Methodology: https://510kreport.com/methodology