# K141097: CSC Series Intraluminal Stapler for Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Touchstone International Medical Science Co., Ltd.
- Decided: Sep 26, 2014 after 151 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: 7 generations back to K940967 (1994). 25 ancestors in all.
No later device cites it as a predicate yet.
6 of 26 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 10.
- K030925: Proximate HCS Hemorrhoidal Circular Stapler and Accessories, Model PPH01, Ethicon Endo-Surgery, Inc. (2003) Summary page 10.

## Indications for use
The CSC Series Intraluminal Stapler for Single Use have applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries. The PPHplus Series PPH Stapler and Purse Sets for Single Use have application for general surgical treatment of hemorrhoids. The TST Series Tissue-Selecting Therapy Stapler have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomuscular tissue.

Source page: https://510kreport.com/device/K141097
Methodology: https://510kreport.com/methodology