# K123318: Idrive Ultra Powered Handle and Endo Gia Adapter

- Pathway: 510(k) (Special)
- Applicant: Covidien, Formerly US Surgical A Divison of Tyco H
- Decided: Dec 18, 2012 after 54 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: 12 generations back to K842066 (1985). 73 ancestors in all.
No later device cites it as a predicate yet.
0 of 74 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 1.

## Indications for use
The iDriveM Ultra powered handle and Endo GIA h adapter, when used with Endo GIA TM single use reloads have applications in abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastoniosis. It may be used for transection and resection of liver substance, hepatic vasculature, and biliary structures and for transection and resection of pancreas. The iDrive t Ultra powered handle and Endo GIAIM adapter, when used with Endo GIA TM curved tip single use reloads, can be used to blunt dissect or separate target tissue from other certain tissue. The iDrive TM Ultra powered handle and Endo GIA Tm adapter, when used with the Endo GIATM Radial Reload with Tni-StapleTm 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 pancreas.

Source page: https://510kreport.com/device/K123318
Methodology: https://510kreport.com/methodology