# K091215: Intelligent Power Unit, Intelligent Console, Intelligent Delivery System, Intelligent Surgical Instrument

- Pathway: 510(k) (Special)
- Applicant: Power Medical Interventions, Inc.
- Decided: May 18, 2009 after 21 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: 9 generations back to K970720 (1997). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 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)
- K073148: Idrives, Idrivec, Idrivef with Vascular Indications, Power Medical Interventions, Inc. (2007) Summary page 2.
- K071708: I45, I45S, I60, and I60S, Power Medical Interventions, Inc. (2007)

## Recalls of this device
- Sep 23, 2009 · Not classified · Z-0409-2010: 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 iDrive Intelligent Power Unit with Console, when used with compatible Intelligent Surgical Instrument Linear Staplers, have 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 iDrive Intelligent Power Unit with [Console, when used with compatible Intelligent Delivery Systems (iStraight, iFlex, iCurve) and Right Angle or Power Linear Cutter Digital Loading Units®, has applications in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, and creation of anastomoses. The iDrive Intelligent Power Unit with iKonsole, when used with compatible Intelligent Delivery Systems and Circular Stapler Digital Loading Units®, has applications for use throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses. The iDrive Intelligent Power Unit with iConsole, when used with compatible Vascular Intelligent Surgical Instruments or Intelligent Delivery Systems with Vascular Digital Loading Units®, has applications for general and endoscopic surgery including multiple open and minimally invasive general, gynecological, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures for resection, transection, and/or creation of anastomoses. They can be used with staple line buttressing material such as bovine pericardium.

Source page: https://510kreport.com/device/K091215
Methodology: https://510kreport.com/methodology