# K131511: Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable Linear Staplers and Reloads, Disposable Hemorr

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Sinolinks Medical Innovation Co., Ltd.
- Decided: Jul 5, 2013 after 38 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). 24 ancestors in all.
14 later devices descend from it; 4 cite it directly.
6 of 39 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 3.
- K091322: Contour Curved Cutter Stapler and Reloads, Models: CS40B, CS40G, CR40B, CR40G, Ethicon Endo-Surgery, Inc. (2009) Summary page 3.

## Most influential descendants
- K141367: LS Series Linear Stapler and Reloads, CLC Series Curved Linear Cutter and Reloads, LC Series Linear Cutter and Reloads (2014), 7 descendants of its own
- K173443: AEON Endoscopic Stapler (2018), 5 descendants of its own
- K182380: AEON Endoscopic Stapler (2018), 4 descendants of its own
- K201882: AEON Endoscopic Stapler (2020), 3 descendants of its own
- K161757: Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and Reloads, Single Use Endoscopic Linear Cutters and Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers and Reloads (2016), 3 descendants of its own

## Indications for use
The Disposable Circular Stapler has applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries. The Disposable Linear Staplers and Reloads have application in the resection or transection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures. The Disposable Hemorrthoidal Staple has application for general surgical treatment of hemorrhoids. The Disposable Endoscopic Linear Cutter Staplers and Reloads 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. The Disposable Linear Cutter Staplers and Reloads have application in abdominal, gynecological, thoracic and pediatric surgery transection, resection, and the creation of anastomoses. The Disposable Curved Cutter Stapler is Intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle), gynecologic, urologic, and thoracic surgical procedures.

Source page: https://510kreport.com/device/K131511
Methodology: https://510kreport.com/methodology