# K172561: Disposable Circular Stapler

- Pathway: 510(k) (Special)
- Applicant: Changzhou Kangdi Medical Stapler Co., Ltd.
- Decided: Dec 5, 2017 after 102 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: 2 generations back to K920752 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100723: Disposable Circular Stapler, Disposable Circular Stapler Model Kygw-25.5, Kygw-28.5, Changzhou Kangdi Medical Stapler Co., Ltd. (2010) Summary page 4.

## Indications for use
The Disposable Circular Stapler has application throughout the alimentary tract for end-to-end, end-to-side and side-to-side anastomoses.

Source page: https://510kreport.com/device/K172561
Methodology: https://510kreport.com/methodology