Medical Device Manufacturer · CN , Xiamen

Cathegenix (Xiamen) Co., Ltd. - FDA 510(k) Cleared Devices

2 submissions · 1 cleared · Since 2025

2

Total

1

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cathegenix (Xiamen) Co., Ltd. Gastroenterology & Urology ✕

2 devices

1-2 of 2

Cleared Dec 19, 2025

Endura™ Ureteral Stent and Stent Set

Gastroenterology & Urology · 220d

Cleared Jun 27, 2025

LumenaTM Ureteral Access Sheath

Gastroenterology & Urology · 120d