The company's ureteral access sheath is cleared via the 510(k) pathway, indicating substantial equivalence to a predicate device for urinary tract access.
Zhejiang Chuangxiang Medical Technology Co., Ltd. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Single Use Ureteral Access Sheath. The decision, dated September 11, 2026, classifies the device as substantially equivalent to existing predicate devices on the market.
This clearance allows the company to market its device for use in accessing the urinary tract, a common procedure in urology. The FDA assigned product code FED and categorized the device under regulation number 876.1500, which pertains to endoscopes and accessories.
Regulatory Pathway and Device Classification
The Single Use Ureteral Access Sheath received clearance through a Special 510(k) submission, utilizing the Summary pathway for documentation. This typically indicates that changes to a previously cleared device, or a device substantially equivalent to one, are being introduced. The device is classified as Class II, a designation for medical devices that pose a moderate risk and require general and special controls to ensure safety and effectiveness.
Devices in this category often undergo a 510(k) premarket notification process, where manufacturers demonstrate substantial equivalence to a legally marketed predicate device that is not subject to premarket approval (PMA). The review was conducted by the Gastroenterology and Urology advisory committee.
Market Implications and Availability
The specific clinical indications, performance data, or detailed technical specifications beyond the device name have not been publicly disclosed in connection with this clearance. Similarly, details regarding the device's availability in the U.S. market, pricing, or the company's distribution strategy are not yet available.
Zhejiang Chuangxiang Medical Technology Co., Ltd. is based in China. The 510(k) clearance represents a critical regulatory step for market entry in the United States, allowing the company to compete in the medical device sector for urological instruments. The clearance does not necessarily imply clinical superiority or novel technological advancement, but rather demonstrates compliance with existing safety and performance standards as benchmarked against predicate devices.
