# K131303: Disposable Circular Stapler

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou City Zhiye Medical Devices Institute Co.
- Decided: Jun 11, 2013 after 35 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: 1 generation back to K920752 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920752: Endopath Ils Endoscopic Circular Stapler, ETHICON, Inc. (1992) Summary page 2.

## 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/K131303
Methodology: https://510kreport.com/methodology