# K211811: Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers

- Pathway: 510(k) (Traditional)
- Applicant: Wuxi Beien Surgery Device Co., Ltd.
- Decided: Mar 3, 2022 after 265 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: 12 generations back to K842066 (1985). 62 ancestors in all.
No later device cites it as a predicate yet.
6 of 63 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 6.
- 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, Victor Medical Instruments Co., Ltd. (2016) Summary page 6.

## Indications for use
The Disposable circular staplers have application throughout the alimentary tract for end to end, end to side, and side to side anastomoses. The Disposable Endoscopic Staplers and Reload Unit have applications in general, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomoses. The Disposable Hemorrhoidal Cutter Staplers have application for general treatment of hemorrhoids. Disposable Linear Cutter Staplers have application in abdominal, gynecological, thoracic and pediatric surgery transection, resection, and the creation of anastomoses.

Source page: https://510kreport.com/device/K211811
Methodology: https://510kreport.com/methodology