# K172538: Disposable Linear Stapler, Disposable Linear Cutter

- Pathway: 510(k) (Special)
- Applicant: Changzhou Kangdi Medical Stapler Co., Ltd.
- Decided: Nov 30, 2017 after 100 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). 59 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121474: Disposable Linear Stapler, Disposable Linear Cutter, Changzhou Kangdi Medical Stapler Co., Ltd. (2012) Summary page 5.

## Indications for use
Disposable Linear Stapler: The Disposable Linear Stapler has application throughout the alimentary tract and in thoracic surgery for transaction and resection of internal tissues. Disposable Linear Cutter: The Disposable Linear Cutter has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.

Source page: https://510kreport.com/device/K172538
Methodology: https://510kreport.com/methodology