# K073001: Idrives, Idrivec, Idrivef

- Pathway: 510(k) (Special)
- Applicant: Power Medical Interventions, Inc.
- Decided: Dec 18, 2007 after 55 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K970720 (1997). 29 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071708: I45, I45S, I60, and I60S, Power Medical Interventions, Inc. (2007) Summary page 1.
- K063746: Power Extenders Model# PEC200, PES200,PES200S, Power Medical Interventions, Inc. (2007) Summary page 1.

## Most influential descendants
- K102325: Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload) (2010), 9 descendants of its own
- 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

## Recalls of this device
- Sep 23, 2009 · Not classified · Z-0406-2010: Lack of assurance that products were manufactured under GMPs. This action is being undertaken due to certain products potentially exhibiting compromised staple formation or cutting which in some insta

## Indications for use
The iDriveS/iDriveC/iDriveF, when used with compatible Linear Digital Loading Units®, has applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, creation of anastomoses, and for open occlusion of the heart's left atrial appendage. The iDriveS/iDriveC/iDriveF, when used with compatible Right Angle Linear Cutter Digital Loading Units®, has applications in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, and creation of anastomoses. The iDriveS/iDriveC/iDriveF, when used with compatible Circular Digital Loading Units®, has applications for use throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.

Source page: https://510kreport.com/device/K073001
Methodology: https://510kreport.com/methodology