# K211458: Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers

- Pathway: 510(k) (Traditional)
- Applicant: Ningbo Verykind Medical Device Co., Ltd.
- Decided: Dec 30, 2021 after 233 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). 63 ancestors in all.
No later device cites it as a predicate yet.
6 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K142577: PANTHER Endo Linear Cutter Staplers with Single Use Loading Units, B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. (2015) Summary page 6.

## Indications for use
The Disposable Anorectal Staplers have application for general treatment of hemorrhoids. The Disposable Linear Cutting Staplers have application in abdominal, gynecological, thoracic and pediatric surgery transection, resection and the creation of anastomoses. The Disposable Endoscopic Cutting Staplers has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transaction and creation of anastomosis.

Source page: https://510kreport.com/device/K211458
Methodology: https://510kreport.com/methodology