# K190331: Applied Medical Laparoscopic Linear Cutter

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources Corporation
- Decided: Nov 22, 2019 after 281 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: 2 generations back to K051002 (2005). 3 ancestors in all.
No later device cites it as a predicate yet.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081146: Echelon Endoscopic Linear Cutters (Articulating and Straight), Ethicon Endo-Surgery, LLC (2008) Summary page 4.

## Indications for use
The Applied Medical Laparoscopic Linear Cutter has applications in open and/ or minimally invasive general, urologic, gynecologic, pediatric and thoracic surgery for resection, transection and/or creation of anastomosis. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen. It can be used with staple line or tissue buttressing materials.

Source page: https://510kreport.com/device/K190331
Methodology: https://510kreport.com/methodology