# K121510: Idrive Ultra Powered Handle Endo Gia Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, Formerly US Surgical A Divison of Tyco H
- Decided: Jul 25, 2012 after 65 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: 11 generations back to K842066 (1985). 72 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102325: Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload), Covidien, LLC, Formerly Registered AS Tyco Healthca (2010) Summary page 1.
- K111825: Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM) Staplers, Covidien, Formerly US Surgical A Divison of Tyco H (2011) Summary page 1.

## Most influential descendants
- K160176: Signia Stapler (2016), 5 descendants of its own
- 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

## Indications for use
The iDrive TM Ultra powered handle and Endo GIA TM 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 anastomosis. 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 T7A Ultra powered handle and Endo GIA TMV adapter, when used with Endo GIA TMV curved tip single use reloads, can be used to blunt dissect or separate target tissue from other certain tissue. The iDrive TmUltra powered handle and Endo GIA TMV adapter, when used with the Endo GIA TMV Radial Reload with Tni-Staple TM 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/K121510
Methodology: https://510kreport.com/methodology