# K211197: Disposable Endoscopic Cutter Stapler and Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Waston Medical Appliance Co., Ltd.
- Decided: Jan 19, 2023 after 638 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)
- 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 5.

## Indications for use
The Disposable Endoscopic Cutter Stapler and Cartridge has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. The Disposable Endoscopic Cutter Stapler and Cartridge is not to be used in the transection and resection of solid organs.

Source page: https://510kreport.com/device/K211197
Methodology: https://510kreport.com/methodology