# K083527: Intelligent Articulating Endoscopic Linear Cutter Reverse with Reloads

- Pathway: 510(k) (Special)
- Applicant: Power Medical Interventions, Inc.
- Decided: Dec 18, 2008 after 20 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). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 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)

## Recalls of this device
- Sep 23, 2009 · Not classified · Z-0407-2010: 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 Endoscopic Linear Cutters Reverse with Reloads have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses.

Source page: https://510kreport.com/device/K083527
Methodology: https://510kreport.com/methodology