Changzhou Sinolinks Medical Innovation Co., Ltd.

Changzhou Sinolinks Medical Innovation Co., Ltd. specializes in single-use surgical stapling devices. Their portfolio includes disposable circular staplers, curved cutter staplers, linear staplers, and reloads for these systems. These devices are designed for tissue approximation and ligation in surgical procedures, such as gastrointestinal anastomoses and wound closure, supporting both minimally invasive and open surgeries.

The company is headquartered in the United States. This location aligns with its focus on manufacturing and distributing medical devices regulated under U.S. standards, including those listed in the FDA’s 510(k) database.

The company’s devices are listed in the FDA’s 510(k) database. This registry is used for Class II medical devices in the U.S., which require pre-market submission to demonstrate substantial equivalence to a legally marketed predicate device before commercial distribution.

The company’s surgical stapling devices fall under Class II classification in the U.S. This classification applies to devices that pose moderate risk and require special controls—such as performance standards, post-market surveillance, or labeling requirements—to ensure safety and effectiveness. Class II devices typically require a 510(k) clearance before marketing.