# K063075: Natural Orifice Linear Cutter Digital Loading Units

- Pathway: 510(k) (Special)
- Applicant: Power Medical Interventions, Inc.
- Decided: Nov 2, 2006 after 27 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: 7 generations back to K970720 (1997). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052415: Power Linear Cutter Reusable Digital Loading Units with Reloads, Power Medical Interventions, Inc. (2005) Summary page 1.

## Indications for use
The Natural Orifice Linear Cutter 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/K063075
Methodology: https://510kreport.com/methodology