# K162710: Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload

- Pathway: 510(k) (Traditional)
- Applicant: Tgs Medical Co., Ltd.
- Decided: Feb 9, 2017 after 134 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). 62 ancestors in all.
No later device cites it as a predicate yet.
4 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030411: Proximate PPH Hemorrhoidal Circular Stapler and Accessories, Model PPH03, Ethicon Endo-Surgery, Inc. (2003) Summary page 7.
- K983536: Proximate Curved and Straight Intraluminal Staplers, Ethicon Endo-Surgery, Inc. (1998) Summary page 7.
- K020779: Proximate and Endopath Linear Cutters and Staplers, Ethicon Endo-Surgery, Inc. (2002) Summary page 7.
- 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.
- K061156: Endopath Endocutter 60 Endoscopic Linear Cutter, Models EC60, SC60 and LONG60 and Endopath & Proximate Linear Cutters, Ethicon Endo-Surgery, Inc. (2006) Summary page 7.
- K062869: Contour Curved Cutter Stapler and Reloads, Models CS40B, CS40G, CR40B and CR40G, Ethicon Endo-Surgery, LLC (2007) Summary page 7.

## Indications for use
The Single Use Circular Stapler has application throughout the alimentary tract for end to end, end to side and side to side anastomoses. The Single Patient Use Endo Cutter and Reload is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. It can be used with tissue buttressing materials. The Single Patient Use Linear Cutter and Reload are intended for use in multiple open or minimally invasive surgical procedures for the transection and resection of tissues. Linear cutters are also intended for creation of anastomoses in these procedures. The Single Patient Use Linear Stapler and Reload has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue and creation of anastomosis, including occlusion of the left atrial appendage in open procedures. They may be used for transection and resection of pancreas. The Single Use Hemorrhoidal Circular Stapler has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease. The Single Patient Use Transverse Cutter and Reload is intended for transection, resection and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle stapling), gynecologic, urologic, and thoracic surgical procedures.

Source page: https://510kreport.com/device/K162710
Methodology: https://510kreport.com/methodology