# K182217: Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Ezisurg (Suzhou) Medical Co., Ltd.
- Decided: Apr 16, 2019 after 244 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: 3 generations back to K821994 (1982). 21 ancestors in all.
No later device cites it as a predicate yet.
2 of 22 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 6.
- K983536: Proximate Curved and Straight Intraluminal Staplers, Ethicon Endo-Surgery, Inc. (1998) Summary page 6.
- K100723: Disposable Circular Stapler, Disposable Circular Stapler Model Kygw-25.5, Kygw-28.5, Changzhou Kangdi Medical Stapler Co., Ltd. (2010) Summary page 6.

## Indications for use
The Linear Cutter Staplers and Loading Units for Single Use have application in gastrointestinal for transection, resection,and/or creation of anastomoses. The Circular Staplers for Single Use has applications throughout the alimentary for end to end, end to side and side to side anastomoses.

Source page: https://510kreport.com/device/K182217
Methodology: https://510kreport.com/methodology