Disposable Ureteral Stents
FDA 510(k) K251890 · Zhejiang Chuangxiang Medical Technology Co., Ltd.
510(k) numberK251890
Submission
- Device name
- Disposable Ureteral Stents
- Applicant
- Zhejiang Chuangxiang Medical Technology Co., Ltd.
Hangzhou, CN - Received
- June 20, 2025
- Decision date
- February 20, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FAD – Stent, Ureteral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4620
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
Other 510(k)s with product code FAD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251469 | Endura Ureteral Stent and Stent SetFAD · Traditional | Cathegenix (Xiamen) Co., Ltd. | 12/19/2025SESK |
| K243039 | Ureteral Stents (AF-D series)FAD · Traditional | Alton (Shanghai) Medical Instruments Co., Ltd. | 06/18/2025SE |
| K243830 | Disposable ureteral stentFAD · Traditional | Shenzhen Trious Medical Technology Co., Ltd. | 05/14/2025SE |
| K250824 | Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive…FAD · Special | Boston Scientific Corporation | 04/15/2025SE |
| K232920 | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit…FAD · Traditional | Ureteral Stent Company | 03/22/2024SE |
| K211934 | APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL…FAD · Traditional | Boston Scientific Corporation | 11/10/2022SESK |
| K213185 | ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop…FAD · Traditional | Coloplast Corp. | 06/08/2022SESK |
| K213444 | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit…FAD · Traditional | Ureteral Stent Company | 03/17/2022SE |
| K213186 | NovoFlow Reinforced Ureteral StentFAD · Traditional | Coloplast Corp. | 02/16/2022SESK |
| K212868 | JFil Ureteral Stents, JFil Ureteral Stents ECO KITFAD · Traditional | Rocamed Sam | 01/26/2022SE |
More from Rocamed Sam
| 510(k) | Device | Decision |
|---|---|---|
| K260410 | Single Use Ureteral Access SheathFED · Special | 09/11/2026SE |
| K253132 | Single use stone retrieval balloonsFGE · Traditional | 03/06/2026SE |
| K230773 | Endoscopy Irrigation TubingOCX · Traditional | 11/21/2023SE |
| K231471 | Air/Water Bottle Tubing, CO2 Source TubingOCX · Traditional | 09/08/2023SE |
| K220063 | Single Use Cytology BrushFDX · Traditional | 07/28/2022SE |
| K212669 | Single Use HemoclipPKL · Traditional | 05/27/2022SE |
| K220065 | Single Use Ureteral Access SheathFED · Traditional | 05/25/2022SE |
| K212668 | Sclerotherapy NeedleFBK · Traditional | 02/23/2022SE |
| K191900 | Single Use Grasping ForcepsOCZ · Traditional | 03/27/2020SE |
| K192258 | Disposable Valve SetsODC · Traditional | 12/30/2019SE |
Questions and answers
When was Disposable Ureteral Stents cleared by the FDA?
Disposable Ureteral Stents (K251890) received a 510(k) decision of Substantially Equivalent on February 20, 2026, 245 days after the submission was received.
What is the product code of K251890?
The FDA product code is FAD – Stent, Ureteral, a Class II (moderate risk) device regulated under 21 CFR 876.4620.