# K202467: Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads

- Pathway: 510(k) (Special)
- Applicant: Fengh Medical Co., Ltd.
- Decided: Dec 14, 2020 after 109 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: 5 generations back to K051002 (2005). 6 ancestors in all.
No later device cites it as a predicate yet.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182476: Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads, Fengh Medical Co., Ltd. (2019) Summary page 5.

## Indications for use
The Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.

Source page: https://510kreport.com/device/K202467
Methodology: https://510kreport.com/methodology