CSC Series Intraluminal Stapler for Single Use
by Touchstone International Medical Science Co., Ltd.
510(k) K141097
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK141097 | Date26 Sep 2014 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GDW
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4750
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The CSC Series Intraluminal Stapler is a surgical stapling device classified as an Implantable Staple (OpenFDA: GDW, Regulation 878.4750). It is designed for intraluminal anastomosis, enabling the creation of end-to-end, end-to-side, and side-to-side connections within the alimentary tract. The device uses a mechanical stapling mechanism to approximate and secure tissue edges, ensuring durable closure during surgical procedures.
This single-use device is intended for use in operating rooms and is supplied sterile, packaged for one-time clinical application. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance (K141097) as substantially equivalent to a predicate device. The CSC Series is available in multiple configurations, as indicated by the listed FEI numbers, and must be handled according to sterile surgical protocols. No MRI safety information is provided, and its reusable or disposable nature is explicitly defined as single-use.
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Questions
AI-generated answers, 1 Oct 2026
What is the CSC Series Intraluminal Stapler used for?
The CSC Series Intraluminal Stapler is designed specifically for intraluminal anastomosis, enabling surgeons to create secure, durable connections within the alimentary tract. It facilitates three types of anastomoses—end-to-end, end-to-side, and side-to-side—using a mechanical stapling mechanism to approximate and secure tissue edges during surgical procedures.
How is the CSC Series Intraluminal Stapler supplied and prepared for use?
The device is supplied sterile and packaged for single-use only. It must be handled according to sterile surgical protocols to maintain its integrity and ensure patient safety. The packaging is designed to preserve sterility until immediate clinical application.
Is the CSC Series Intraluminal Stapler reusable or single-use?
The CSC Series Intraluminal Stapler is explicitly designed for single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility, functionality, and patient safety.
What configurations or models are available for the CSC Series Intraluminal Stapler?
The CSC Series is available in multiple configurations, each identified by a unique FEI number. These variations accommodate different surgical needs and anatomical requirements. The full list of FEI numbers is provided in the regulatory documentation, ensuring compatibility with various clinical scenarios.
How should the CSC Series Intraluminal Stapler be stored?
The device must be stored in its original, unopened sterile packaging to preserve sterility. It should be kept in a clean, dry environment, protected from physical damage, extreme temperatures, and direct sunlight. Follow manufacturer guidelines for proper storage conditions to maintain device performance and integrity.