# K161905: Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd
- Decided: Nov 17, 2016 after 129 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: 7 generations back to K940967 (1994). 25 ancestors in all.
No later device cites it as a predicate yet.
6 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131511: Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable Linear Staplers and Reloads, Disposable Hemorr, Changzhou Sinolinks Medical Innovation Co., Ltd. (2013) Summary page 6.
- K120179: Reach Surgical Staplers, Reach Surgical, Inc. (2012) Summary page 6.

## Indications for use
The Disposable Circular Stapler has applications throughout the alimentary tract for the creation of end-to-end, end-to-side anastomoses in both open and laparoscopic surgeries. The Disposable Linear Stapler has application in the resection or transection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures. The Disposable Endoscopic Linear Cutter Stapler and Cartridge has 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 and biliary structures. The Disposable Linear Cutter Stapler and Stapler Cartridge has application in abdominal, gynecological, thoracic and pediatric surgery transection, resection and the creation of anastomoses. Disposable Circular Stapler for Hemorrhoids has application for general treatment of hemorrhoids

Source page: https://510kreport.com/device/K161905
Methodology: https://510kreport.com/methodology