# K161757: Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and Reloads, Single Use Endoscopic Linear Cutters and Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers and Reloads

- Pathway: 510(k) (Traditional)
- Applicant: Victor Medical Instruments Co., Ltd.
- Decided: Dec 5, 2016 after 161 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). 61 ancestors in all.
3 later devices descend from it; 3 cite it directly.
6 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131511: Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable Linear Staplers and Reloads, Disposable Hemorr, Changzhou Sinolinks Medical Innovation Co., Ltd. (2013) 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 7.

## Most influential descendants
- K211197: Disposable Endoscopic Cutter Stapler and Cartridge (2023), 0 descendants of its own
- K211811: Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers (2022), 0 descendants of its own
- K211458: Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers (2021), 0 descendants of its own

## Indications for use
The Single Use Endoscopic Linear Cutters and Reloads have 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 Single Use Curved Cutters are intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle), gynecologic, urologic, and thoracic surgical procedures. The Single Use Circular staplers have application throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in abdominal or thoracic surgeries. The Single Use Linear Staplers and Reloads have application in the resection or transection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures. The Single Use Linear Cutters and Reloads have application in abdominal, gynecological, thoracic and pediatric surgery transection, resection and the creation of anastomoses. The Single Use Hemorrhoidal Staplers have application for general treatment of hemorrhoids.

Source page: https://510kreport.com/device/K161757
Methodology: https://510kreport.com/methodology