# K121474: Disposable Linear Stapler, Disposable Linear Cutter

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Kangdi Medical Stapler Co., Ltd.
- Decided: Jul 16, 2012 after 59 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: 11 generations back to K842066 (1985). 58 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020779: Proximate and Endopath Linear Cutters and Staplers, Ethicon Endo-Surgery, Inc. (2002) Summary page 1.
- K111825: Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM) Staplers, Covidien, Formerly US Surgical A Divison of Tyco H (2011) Summary page 1.

## Most influential descendants
- K172538: Disposable Linear Stapler, Disposable Linear Cutter (2017), 0 descendants of its own

## Indications for use
The Disposable Linear Stapler has application throughout the alimentary tract and in thoracic surgery for transaction and resection of internal tissues. 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/K121474
Methodology: https://510kreport.com/methodology