Endura Ureteral Stent and Stent Set— 510(k) K251469

Unknown

Cathegenix (Xiamen) Co., Ltd.

FDA 510(k) clearance K251469 for Endura Ureteral Stent and Stent Set, Unknown on 2025-12-19. Applicant: Cathegenix (Xiamen) Co., Ltd..

Clearance details

Applicant: Cathegenix (Xiamen) Co., Ltd.
Product code: Code FAD
Advisory panel: Gastroenterology, Urology
Date received: 2025-05-13
Decision date: 2025-12-19
Decision: Unknown
Clearance type: Traditional
Location: Xiamen, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FAD

product code FAD

Death: 2
Injury: 858
Malfunction: 2,651
Other: 1
Total: 3,512

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.