# K130738: Endoscopic Linear Cutting Staplers with Single Use Loading Units

- Pathway: 510(k) (Traditional)
- Applicant: Nanjing Maidixin Medical Device Co., Ltd.
- Decided: Dec 13, 2013 after 270 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: 6 generations back to K940967 (1994). 18 ancestors in all.
No later device cites it as a predicate yet.
6 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120179: Reach Surgical Staplers, Reach Surgical, Inc. (2012) Summary page 1.

## Indications for use
The Endoscopic Linear Cutting Staplers with Single Use Loading Units have applications in general, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.

Source page: https://510kreport.com/device/K130738
Methodology: https://510kreport.com/methodology