FAD
- Product code
- FAD
- Device name
- Stent, Ureteral
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.4620
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- Flag
- Implant
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 6
- Summaries archived here
- 5 (direct download)
- 510(k) clearances (all years, FDA)
- 122 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (6)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251890 | 2026-02-20 | Zhejiang Chuangxiang Medical Technolog… | Disposable Ureteral Stents | |
| K251469 | 2025-12-19 | Cathegenix (Xiamen) Co., Ltd. | Endura Ureteral Stent and Stent Set | |
| K243039 | 2025-06-18 | Alton (Shanghai) Medical Instruments C… | Ureteral Stents (AF-D series) | |
| K243830 | 2025-05-14 | Shenzhen Trious Medical Technology Co.… | Disposable ureteral stent | |
| K250824 | 2025-04-15 | Boston Scientific Corporation | Percuflex Ureteral Stent; Percuflex Plus Ureteral St… | |
| K232920 | 2024-03-22 | Ureteral Stent Company | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 2… | FDA |
Official FDA classification page: FAD
Classification and pathway per current FDA publications. Data from openFDA (CC0).