# K162947: Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit; Linear Cutting Stapler and Single Use Loading Unit; Disposal Hemorrhoidal Circular Stapler

- Pathway: 510(k) (Traditional)
- Applicant: Chongqing Qmi Surgical Co., Ltd.
- Decided: Mar 3, 2017 after 133 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). 46 ancestors in all.
No later device cites it as a predicate yet.
1 of 47 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062850: Autosuture Circular Eea Surgical Staplers, United States Surgical, A Division of Tyco Healthc (2006) Summary page 6.
- 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 6.
- K051301: Proximate PPH Hemorrhoidal Circular Stapler and Accessories, Ethicon Endo-Surgery, Inc. (2005) Summary page 6.
- K061156: Endopath Endocutter 60 Endoscopic Linear Cutter, Models EC60, SC60 and LONG60 and Endopath & Proximate Linear Cutters, Ethicon Endo-Surgery, Inc. (2006) Summary page 6.

## Indications for use
The Disposable End-to-end Anastomosis Circular Stapler has applications throughout the alimentary tract for the creation of end-to end, side-to-side and end-to-side anastomoses in both open and laparoscopic surgeries, including bariatric surgery. The Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas. The Linear Cutting Stapler and Single Use Loading Unit has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis. The stapler may be used for occlusion of the left atrial appendage in open procedures. They may be used for transection and resection of pancreas. The Disposable Hemorrhoidal Circular Stapler has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.

Source page: https://510kreport.com/device/K162947
Methodology: https://510kreport.com/methodology