# K102325: Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload)

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC, Formerly Registered AS Tyco Healthca
- Decided: Oct 13, 2010 after 57 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: 9 generations back to K970720 (1997). 35 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073001: Idrives, Idrivec, Idrivef, Power Medical Interventions, Inc. (2007) Summary page 1.
- K012809: Surgassist Right Angle Linear Cutter Dlu - 45MM, Model RALC45, Power Medical Interventions, Inc. (2001) Summary page 1.
- K091322: Contour Curved Cutter Stapler and Reloads, Models: CS40B, CS40G, CR40B, CR40G, Ethicon Endo-Surgery, Inc. (2009) Summary page 1.
- K801589: Auto Suture Disp. 30, Etc. & Surg. Stap, United States Surgical, A Division of Tyco Healthc (1980) Summary page 1.

## Cited in the summary but kept off the family tree
- K011386: Ebi Osteostim Granules-Resorbable Bone Graft Substitute, Ebi, L.P. (2001). Our reading of the summary gave K011386, FDA’s number for Ebi Osteostim Granules-Resorbable Bone Graft Substitute (Ebi, L.P.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Covidien, Autosuture TA DST Series Stapler”. Kept off the family tree.

## 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
- 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

## Indications for use
The iDrive™ Powered Handle, when used with the iDrive™ Right Angle Linear Cutter (RALC) Single Use Reload, is intended for use in gastrointestinal, gynecological, and general abdominal and thoracic surgery for resection, transection of tissues, and creation of anastomoses. The iDrive™ Right Angle Linear Cutter (RALC) Single Use Reload, when used with the iDrive™ Powered Handle, is intended for use in gastrointestinal, gynecological, and general abdominal and thoracic surgery for resection, transection of tissues, and creation of anastomoses.

Source page: https://510kreport.com/device/K102325
Methodology: https://510kreport.com/methodology