Endura Ureteral Stent and Stent Set
FDA 510(k) K251469 · Cathegenix (Xiamen) Co., Ltd.
510(k) numberK251469
Submission
- Device name
- Endura Ureteral Stent and Stent Set
- Applicant
- Cathegenix (Xiamen) Co., Ltd.
Xiamen, CN - Received
- May 13, 2025
- Decision date
- December 19, 2025
- Decision
- Unknown (SESK)
- 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 |
|---|---|---|---|
| K251890 | Disposable Ureteral StentsFAD · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 02/20/2026SE |
| 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 |
|---|---|---|
| K250585 | LumenaTM Ureteral Access SheathFED · Traditional | 06/27/2025SE |
Questions and answers
When was Endura Ureteral Stent and Stent Set cleared by the FDA?
Endura Ureteral Stent and Stent Set (K251469) received a 510(k) decision of Unknown on December 19, 2025, 220 days after the submission was received.
What is the product code of K251469?
The FDA product code is FAD – Stent, Ureteral, a Class II (moderate risk) device regulated under 21 CFR 876.4620.