# K052415: Power Linear Cutter Reusable Digital Loading Units with Reloads

- Pathway: 510(k) (Special)
- Applicant: Power Medical Interventions, Inc.
- Decided: Sep 29, 2005 after 27 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: 6 generations back to K970720 (1997). 25 ancestors in all.
15 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)
- K040720: Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55 MM, 75 MM, Power Medical Interventions, Inc. (2004) Summary page 1.

## Most influential descendants
- K063746: Power Extenders Model# PEC200, PES200,PES200S (2007), 13 descendants of its own
- K073001: Idrives, Idrivec, Idrivef (2007), 11 descendants of its own
- 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

## Recalls of this device
- May 12, 2007 · Not classified · Z-1099-2007: Malfunction - improper staple formation

## Indications for use
The Power Linear Cutter Reusable Digital Loading Units® with Reloads 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.

Source page: https://510kreport.com/device/K052415
Methodology: https://510kreport.com/methodology