FAD · Stent, Ureteral
Gastroenterology, Urology · 21 CFR 876.4620 · Class 2
Overview
| Product Code | FAD |
|---|---|
| Device Name | Stent, Ureteral |
| Regulation | 21 CFR 876.4620 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| 3rd-Party Reviewable | Yes |
| Implant | Yes |
Identification
A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 122)
Showing 20 most recent of 122 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251890 | Disposable Ureteral Stents | Zhejiang Chuangxiang Medical Technology Co., Ltd. | Feb 20, 2026 | SESE |
| K251469 | Endura Ureteral Stent and Stent Set | Cathegenix (Xiamen) Co., Ltd. | Dec 19, 2025 | SESK |
| K243039 | Ureteral Stents (AF-D series) | Alton (Shanghai) Medical Instruments Co., Ltd. | Jun 18, 2025 | SESE |
| K243830 | Disposable ureteral stent | Shenzhen Trious Medical Technology Co., Ltd. | May 14, 2025 | SESE |
| K250824 | Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set | Boston Scientific Corporation | Apr 15, 2025 | SESE |
| K232920 | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm | Ureteral Stent Company | Mar 22, 2024 | SESE |
| K211934 | APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg | Boston Scientific Corporation | Nov 10, 2022 | SESK |
| K213185 | ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits | Coloplast Corp. | Jun 8, 2022 | SESK |
| K213444 | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm | Ureteral Stent Company | Mar 17, 2022 | SESE |
| K213186 | NovoFlow Reinforced Ureteral Stent | Coloplast Corp. | Feb 16, 2022 | SESK |
| K212868 | JFil Ureteral Stents, JFil Ureteral Stents ECO KIT | Rocamed Sam | Jan 26, 2022 | SESE |
| K200260 | Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System | Boston Scientific Corporation | Apr 26, 2021 | SESK |
| K201436 | Vortek Single Loop Ureteral Stent | Coloplast Corp. | Feb 25, 2021 | SESE |
| K191446 | Ureteral Stent Systems, Biliary Drainage Catheters | Boston Scientific Corporation | Jan 2, 2020 | SESK |
| K190659 | Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip | Allwin Medical Devices, Inc. | Dec 2, 2019 | SESK |
| K190312 | Dornier Ureteral Stent | Dornier Medtech America, Inc. | Nov 15, 2019 | SESE |
| K191609 | Tria Soft Ureteral Stent | Boston Scientific Corporation | Aug 16, 2019 | SESE |
| K190603 | Tria Firm Ureteral Stent | Boston Scientific Corporation | May 24, 2019 | SESE |
| K181971 | Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set | Cook Incorporated | Apr 23, 2019 | SESK |
| K180557 | Greene Renal Transplant Stent Set | Cook Incorporated | Nov 23, 2018 | SESE |
Top Applicants
- Cook Incorporated — 13 clearances
- Surgitek — 9 clearances
- Mentor Corp. — 8 clearances
- Boston Scientific Corporation — 7 clearances
- C.R. Bard, Inc. — 7 clearances
