# K081826: Intelligent Straight and Articular Endoscopic Linear Cutters, Vascular with Reloads, Models I30V, I45V, 160V, IR30V

- Pathway: 510(k) (Special)
- Applicant: Power Medical Interventions, Inc.
- Decided: Jul 25, 2008 after 28 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: 7 generations back to K970720 (1997). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 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.
- K022313: Surgassist Right Angle Linear Cutter Dlu 30MM, 45MM & 60MM - Vascular with Reloads, Models RALC30V, RALC45V & RALC60V, Power Medical Interventions, Inc. (2002) Summary page 1.

## Recalls of this device
- Sep 23, 2009 · Not classified · Z-0408-2010: 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 Intelligent Articulating and Straight Endoscopic Linear Cutters - Vascular with Reloads have applications for general and endoscopic surgery including multiple open or minimally invasive general, gynecological, urologic (including radical prostatectomy) thoracic, and pediatric surgical procedures for transaction, resection, and/or creation of anastomoses. They can be used with staple line or tissue buttressing material such as bovine pericardium.

Source page: https://510kreport.com/device/K081826
Methodology: https://510kreport.com/methodology