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FDA PRODUCT CODE · CLASS II

FAD — Stent, Ureteral

DEVICE CLASS
Class II
REGULATION
21 CFR 876.4620
MEDICAL SPECIALTY
Gastroenterology, Urology
REVIEW PANEL
GU
✓ Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
5
510(K)/PMA CLEARANCES
510k: 5
0
RECALL ENTRIES

Recent clearances

K251890Zhejiang Chuangxiang Medical Technology Co., Ltd. · 510k2026-02-20
K251469Cathegenix (Xiamen) Co., Ltd. · 510k2025-12-19
K243039Alton (Shanghai) Medical Instruments Co., Ltd. · 510k2025-06-18
K243830Shenzhen Trious Medical Technology Co., Ltd. · 510k2025-05-14
K250824Boston Scientific Corporation · 510k2025-04-15

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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