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).
Cleared Devices (122)
| 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 |
| K180469 | ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent | Coloplast Corp. | Nov 6, 2018 | SESE |
| K180216 | Seidmon Antegrade AQ Stent Set | Cook Incorporated | Sep 28, 2018 | SESE |
| K180029 | Malecot Nephrostomy Catheter/Stent Set | Cook Incorporated | Sep 21, 2018 | SESE |
| K180053 | Sof-Flex Ureteral Stent Set | Cook Incorporated | Sep 13, 2018 | SESE |
| K171603 | Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set | Cook Incorporated | Apr 16, 2018 | SESK |
| K172017 | Black Silicone Filiform Double Pigtail Stent Set | Cook Incorporated | Mar 26, 2018 | SESK |
| K173734 | RocaJJ Soft Stents | Promepla Sam | Mar 12, 2018 | SESE |
| K180057 | VORTEK URETERAL DOUBLE LOOP STENT | Coloplast Corp. | Mar 9, 2018 | SESE |
| K170362 | VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS | Coloplast Corp. | Nov 15, 2017 | SESE |
| K170422 | BIOSOFT DUO DOUBLE LOOP URETERAL STENTS | Coloplast Corp. | Nov 2, 2017 | SESE |
| K172289 | pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent | Q Urological Corporation | Oct 4, 2017 | SESE |
| K170010 | Salle Intraoperative Pyeloplasty Stent Set | Cook Incorporated | Aug 28, 2017 | SESE |
| K163399 | Tria Firm Ureteral Stent | Boston Scientific Corporation | Jun 22, 2017 | SESE |
| K162109 | Kwart Retro-Inject Ureteral Stent | Cook Incorporated | Jun 7, 2017 | SESE |
| K162104 | C-Flex Ureteral Stent Set | Cook Incorporated | Apr 24, 2017 | SESK |
| K161236 | Universa Firm Ureteral Stents and Stent Sets | Cook Incorporated | Jan 27, 2017 | SESE |
| K163068 | pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent | Q Urological Corporation | Dec 22, 2016 | SESE |
| K161277 | ConvertX Nephroureteral Stent System | Brightwater Medical | Nov 22, 2016 | SESE |
| K160891 | Ultrathane Endoureterotomy Stent Set | Cook Incorporated | Jun 24, 2016 | SESE |
| K151051 | Universa Soft Ureteral Stents and Stent Sets | Cook Incorporated | Jan 11, 2016 | SESE |
| K141344 | EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM | Boston Scientific Corp | Oct 17, 2014 | SESE |
| K082805 | PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX | Q Urological Corporation | Jan 20, 2010 | SESE |
| K072293 | FOSSA URETERAL OPEN STENTS | Fossa Medical, Inc. | Aug 6, 2008 | SESE |
| K063742 | RESONANCE METALLIC URETERAL STENT | Cook Ireland, Ltd. | May 8, 2007 | SESE |
| K060673 | PEDIATRIC URETERAL STENT | Applied Medical Resources Corp. | Mar 29, 2006 | SESE |
| K033210 | BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET | Bioteque Corp. | Dec 30, 2004 | SESE |
| K043193 | BARD INLAYOPTIMA URETERAL STENT WITH SUTURE | C.R. Bard, Inc. | Dec 7, 2004 | SESE |
| K040760 | MODIFICATION TO URETERAL STENT | Applied Medical Resources Corp. | Oct 15, 2004 | SESE |
| K031292 | MODIFICATION TO FOSSA URETERAL STONE SWEEPER | Fossa Medical, Inc. | May 22, 2003 | SESE |
| K030503 | MODIFICATION TO CONTOUR POLARIS URETERAL STENT | Boston Scientific Corp | Mar 17, 2003 | SESE |
| K022447 | BARD ER URETERAL STENT WITH SUTURE | C.R. Bard, Inc. | Jan 23, 2003 | SESE |
| K013921 | PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X | Porges S.A. | Oct 17, 2002 | SESE |
| K013784 | URETERAL STENT | Boston Scientific Corp | Aug 8, 2002 | SESE |
| K021602 | FOSSA URETERAL STONE SWEEPER | Fossa Industries, Inc. | Jul 26, 2002 | SESE |
| K021140 | FOSSA EXPANDING DOUBLE PIGTAIL URETERAL STENT | Fossa Industries, Inc. | Jun 28, 2002 | SESE |
| K011264 | MESH URETERAL STENT | Applied Medical Resources Corp. | Jul 17, 2001 | SESE |
| K010002 | CONTOUR POLARIS URETERAL STENT | Boston Scientific Corp | Jan 22, 2001 | SESE |
| K992391 | UROSURGE SPIRALFLO URETERAL STENT | Urosurge, Inc. | Aug 18, 1999 | SESE |
| K982974 | DD URETERAL STENT, INTEGRAL STENT | Rusch Intl. | Jul 2, 1999 | SESE |
| K991219 | C-FLEX URETERAL STENTS | Applied Medical Resources | Jun 21, 1999 | SESE |
| K983498 | BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER REFERRED TO AS BARD LUBRICIOUS URETERAL STE | C.R. Bard, Inc. | Dec 15, 1998 | SESE |
| K981591 | VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT | International Regulatory Consultants | Oct 9, 1998 | SESE |
| K981491 | UROSURGE FILASTENT URETERAL STENT | Urosurge, Inc. | May 29, 1998 | SESE |
| K981489 | UROSURGE SPIRASTENT PLUS URETERAL STENT | Urosurge, Inc. | May 29, 1998 | SESE |
| K974541 | MODIFIED URETERAL INDWELLING CATHETER/STENT | Boston Scientific Corp | Feb 9, 1998 | SESE |
| K973504 | UROSURGE UROSTENT | Princeton Regulatory Assoc. | Jan 30, 1998 | SESE |
| K961371 | SUBCUTANEOUS URINARY DIVERSON STENT SET | Cook Urological, Inc. | Jul 24, 1996 | SESE |
| K952513 | LESE STENTS SETS | Cook Urological, Inc. | Jun 10, 1996 | SESE |
| K961446 | AQ HYDROPHILIC STENT | Cook Urological, Inc. | May 28, 1996 | SESE |
| K960148 | CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENT | Cabot Medical Corp. | Mar 25, 1996 | SESE |
| K946296 | QUADRA-COIL URETERAL STENT | Surgitek | Mar 6, 1995 | SESE |
| K930731 | SLIP-COAT STENTS | Cook Urological, Inc. | Dec 8, 1994 | SESE |
| K941952 | SURGITEK INFUSER | Surgitek | May 24, 1994 | SESE |
| K933941 | MENLO CARE URINARY DIVERSION STENT | Menlo Care, Inc. | Mar 31, 1994 | SESE |
| K923394 | MENLO CARE AQUASTENT SET | Menlo Care, Inc. | Nov 16, 1993 | SESE |
| K930733 | URETERAL STENT | Surgitek | Jul 23, 1993 | SESE |
| K930882 | UROLOGICAL CATHETER & ACCESSORIES | Applied Medical Resources | Jul 8, 1993 | SESE |
| K925282 | UROLOGICAL CATHETER AND ACCESSORIES | Applied Urology, Inc. | Jan 13, 1993 | SESE |
| K920695 | URETERAL STENT | Applied Urology, Inc. | Sep 23, 1992 | SESE |
| K914280 | ECHOSIGHT STENT SET | Cook Urological, Inc. | Jan 9, 1992 | SESE |
| K913928 | SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT | Surgitek Medical Engineering Corp. | Nov 19, 1991 | SESE |
| K912060 | MENTOR BLACK LIGHT INJECTION STENT SET | Mentor Corp. | Sep 27, 1991 | SESE |
| K910691 | NORTEC URETERAL STENT | North American Sterilization & Packaging Co. | Aug 15, 1991 | SESE |
| K903345 | BARD (R) LUBRICIOUS - COATED URETERAL STENT SUTURE | C.R. Bard, Inc. | Apr 30, 1991 | SESE |
| K905505 | VAS-CATH URETERAL STENTS CATHETER, MODIFICATION | Vas-Cath, Inc. | Apr 9, 1991 | SESE |
| K905289 | SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT | Medical Engineering Corp. | Mar 13, 1991 | SESE |
| K904231 | MODEL OSP, SANDHILL AMS | Sandhill Scientific, Inc. | Jan 2, 1991 | SESE |
| K894357 | VAS-CATH URETERAL STENT CATHETER | Vas-Cath, Inc. | Oct 3, 1989 | SESE |
| K883561 | BARD(R) URETERAL STENT W/SUTURE | C.R. Bard, Inc. | Nov 15, 1988 | SESE |
| K882157 | PANAMEX(TM) URETERAL STENT | Kingston Technologies, Inc. | Aug 2, 1988 | SESE |
| K881744 | PORGES URETERAL STENT | Bivona Medical Technologies | May 3, 1988 | SESE |
| K880660 | SURGITEK SUPER DOUBLE J URETERAL STENT KIT | Surgitek | Apr 14, 1988 | SESE |
| K875038 | MENTOR UNISTENT URETERAL STENT SET | Mentor Corp. | Mar 3, 1988 | SESE |
| K873557 | MENTOR BLACK LIGHT URETERAL STENT SET | Mentor Corp. | Feb 11, 1988 | SESE |
| K872353 | SURGITEK INFUSION STENT SYSTEM* | Surgitek | Sep 16, 1987 | SESE |
| K871667 | URETERAL STENT | Penn Medical Devices, Inc. | Jun 10, 1987 | SESE |
| K871291 | AM CATH ESWL STENT | Inter-Med Corp. | Apr 30, 1987 | SESE |
| K865085 | KAMINSKY COMBINATION STENT & INJECTION CATHETER | Van-Tec, Inc. | Mar 25, 1987 | SESE |
| K864225 | ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT | Angiomed U.S., Inc. | Jan 30, 1987 | SESE |
| K864669 | AM CATH ESWL STENT | Inter-Med Corp. | Jan 5, 1987 | SESE |
| K863492 | METAL TIPPED URETER. STENT & MAGNETIC STENT RETRI. | Surgitek | Dec 18, 1986 | SESE |
| K862539 | SILICONE DOUBLE COIL URETERAL STENT WITH SUTURE | Mentor Corp. | Sep 9, 1986 | SESE |
| K861478 | BARD DOUBLE PIGTAIL URETERAL STENT | C.R. Bard, Inc. | May 15, 1986 | SESE |
| K860267 | MARDIS DANGLER URETERAL STENT SET | Van-Tec, Inc. | Apr 3, 1986 | SESE |
| K854908 | UROFLEX | Angiomed U.S., Inc. | Mar 14, 1986 | SESE |
| K860055 | MENTOR SINGLE COIL URINARY DIVERSION STENT SET | Mentor Corp. | Mar 11, 1986 | SESE |
| K854862 | CURITY URETERAL STENT | The Kendal Co. | Feb 10, 1986 | SESE |
| K852389 | URETERAL STENT | American Medical Systems, Inc. | Sep 5, 1985 | SESE |
| K851870 | MENTOR UNIVERSAL URETERAL STENT SET | Mentor Corp. | Jul 2, 1985 | SESE |
| K850175 | MENTOR DBL-COIL INDWELL. SILICONE URETERAL STENT S | Mentor Corp. | Mar 7, 1985 | SESE |
| K850176 | MENTOR DBL-COIL INDWELLING POLYURETHANE URETERAL- | Mentor Corp. | Feb 28, 1985 | SESE |
| K833782 | SURGITEK ALL SILICONE INFECTION DOUBJ | Surgitek | Apr 2, 1984 | SESE |
| K834401 | URETERAL DOUBLE PIGTAIL STENT | Hobbs Medical, Inc. | Mar 22, 1984 | SESE |
| K840059 | SILITEK URINARY DIVERSION STENT | Surgitek | Feb 4, 1984 | SESE |
| K832915 | URETHRAL OBSTRUCT PRIMARY EXCHANGE STEN | Surgitek | Oct 14, 1983 | SESE |
| K831857 | SURGITEK PERCUTANEOUS ARNEGRADE SILITEK | Medical Engineering Corp. | Aug 11, 1983 | SESE |
| K831446 | SURGITEK NEPHROSTENT KIT | Mec/Surgitek Products | Jun 22, 1983 | SESE |
| K823487 | BARD URETERAL STENT | C.R. Bard, Inc. | May 27, 1983 | SESE |
| K830884 | SURGITEKS PERCUTANEOUS ANTEGRADE ALL - | Medical Engineering Corp. | May 9, 1983 | SESE |
| K820870 | URETERAL STANT SET | Van-Tec, Inc. | Apr 26, 1982 | SESE |
| K800109 | SURGITEK URINARY DIVERSION STENT | Medical Engineering Corp. | Feb 26, 1980 | SESE |
| K781641 | SURGITEK DOUBLE J URETEROL STENT | Medical Engineering Corp. | Dec 7, 1978 | SESE |
Top Applicants
- Cook Incorporated — 13 clearances
- Surgitek — 9 clearances
- Mentor Corp. — 8 clearances
- Coloplast Corp. — 7 clearances
- C.R. Bard, Inc. — 7 clearances
