Porges Silicone Double Loop Ureteral Stent, Model # AJ4X / BJ1X / BJ2X
FDA 510(k) K013921 · Porges S.A.
510(k) numberK013921
Submission
- Device name
- Porges Silicone Double Loop Ureteral Stent, Model # AJ4X / BJ1X / BJ2X
- Applicant
- Porges S.A.
Le Plessis Robinson Cedex, FR - Received
- November 27, 2001
- Decision date
- October 17, 2002
- 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 |
|---|---|---|---|
| K251890 | Disposable Ureteral StentsFAD · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 02/20/2026SE |
| 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 |
More from Coloplast Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K021856 | Porges Ureteral Catheters, Models ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX…EYB · Traditional | 10/17/2002SE |
| K013174 | Proges Folysil Silicone Foley Catheter, Straight Cylindrical Tip, Silicone Female Foley…EZL · Abbreviated | 01/04/2002SE |
| K013172 | Porges Silicone Prostatectomy Catheter, Straight Cylindrical Tip, Delinotte Tip, Dufour…EZL · Abbreviated | 12/20/2001SE |
Questions and answers
When was Porges Silicone Double Loop Ureteral Stent, Model # AJ4X / BJ1X / BJ2X cleared by the FDA?
Porges Silicone Double Loop Ureteral Stent, Model # AJ4X / BJ1X / BJ2X (K013921) received a 510(k) decision of Substantially Equivalent on October 17, 2002, 324 days after the submission was received.
What is the product code of K013921?
The FDA product code is FAD – Stent, Ureteral, a Class II (moderate risk) device regulated under 21 CFR 876.4620.