# K100386: Disposable Circular Stapler, Models Why-25, Why-29. Why 32

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Waston Medical Appliance Co., Ltd.
- Decided: Mar 1, 2010 after 13 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: 5 generations back to K940967 (1994). 14 ancestors in all.
No later device cites it as a predicate yet.
5 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090821: Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L, Frankenman International Limited (2009) Summary page 1.

## Indications for use
The Disposable Circular Stapler is intended to be used throughout the alimentary tract for the creation of end-to-end and end-to-side anastomosis.

Source page: https://510kreport.com/device/K100386
Methodology: https://510kreport.com/methodology