Product Code: FAD FDA class 2 21 CFR 876.4620

Stent, Ureteral

Gastroenterology, Urology

The Ureteral Stent (product code FAD) is an implantable tubular device placed within the ureter to maintain patency and facilitate urine drainage from the kidney to the bladder, commonly used after urological procedures or to relieve obstructions. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.4620 in the Gastroenterology and Urology specialty. This device is designated as an implant and is eligible for third-party 510(k) review.

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510(k)s

122

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FAD
Device Class: FDA class 2
Regulation Number: 876.4620
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 122 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251890	Disposable Ureteral Stents	Feb 20, 2026	Substantially Equivalent	Zhejiang Chuangxiang Medical Technology Co., Ltd.
K251469	Endura Ureteral Stent and Stent Set	Dec 19, 2025	Unknown	Cathegenix (Xiamen) Co., Ltd.
K243039	Ureteral Stents (AF-D series)	Jun 18, 2025	Substantially Equivalent	Alton (Shanghai) Medical Instruments Co., Ltd.
K243830	Disposable ureteral stent	May 14, 2025	Substantially Equivalent	Shenzhen Trious Medical Technology Co., Ltd.
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	Apr 15, 2025	Substantially Equivalent	Boston Scientific Corporation
K232920	RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm	Mar 22, 2024	Substantially Equivalent	Ureteral Stent Company
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	Nov 10, 2022	Unknown	Boston Scientific Corporation
K213185	ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits	Jun 08, 2022	Unknown	Coloplast Corp.
K213444	RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm	Mar 17, 2022	Substantially Equivalent	Ureteral Stent Company
K213186	NovoFlow Reinforced Ureteral Stent	Feb 16, 2022	Unknown	Coloplast Corp.
K212868	JFil Ureteral Stents, JFil Ureteral Stents ECO KIT	Jan 26, 2022	Substantially Equivalent	Rocamed Sam
K200260	Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System	Apr 26, 2021	Unknown	Boston Scientific Corporation
K201436	Vortek Single Loop Ureteral Stent	Feb 25, 2021	Substantially Equivalent	Coloplast Corp.
K191446	Ureteral Stent Systems, Biliary Drainage Catheters	Jan 02, 2020	Unknown	Boston Scientific Corporation
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	Dec 02, 2019	Unknown	Allwin Medical Devices, Inc.
K190312	Dornier Ureteral Stent	Nov 15, 2019	Substantially Equivalent	Dornier Medtech America, Inc.
K191609	Tria Soft Ureteral Stent	Aug 16, 2019	Substantially Equivalent	Boston Scientific Corporation
K190603	Tria Firm Ureteral Stent	May 24, 2019	Substantially Equivalent	Boston Scientific Corporation
K181971	Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set	Apr 23, 2019	Unknown	Cook Incorporated
K180557	Greene Renal Transplant Stent Set	Nov 23, 2018	Substantially Equivalent	Cook Incorporated
K180469	ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent	Nov 06, 2018	Substantially Equivalent	Coloplast Corp.
K180216	Seidmon Antegrade AQ Stent Set	Sep 28, 2018	Substantially Equivalent	Cook Incorporated
K180029	Malecot Nephrostomy Catheter/Stent Set	Sep 21, 2018	Substantially Equivalent	Cook Incorporated
K180053	Sof-Flex Ureteral Stent Set	Sep 13, 2018	Substantially Equivalent	Cook Incorporated
K171603	Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set	Apr 16, 2018	Unknown	Cook Incorporated
K172017	Black Silicone Filiform Double Pigtail Stent Set	Mar 26, 2018	Unknown	Cook Incorporated
K173734	RocaJJ Soft Stents	Mar 12, 2018	Substantially Equivalent	Promepla Sam
K180057	VORTEK URETERAL DOUBLE LOOP STENT	Mar 09, 2018	Substantially Equivalent	Coloplast Corp.
K170362	VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS	Nov 15, 2017	Substantially Equivalent	Coloplast Corp.
K170422	BIOSOFT DUO DOUBLE LOOP URETERAL STENTS	Nov 02, 2017	Substantially Equivalent	Coloplast Corp.
K172289	pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent	Oct 04, 2017	Substantially Equivalent	Q Urological Corporation
K170010	Salle Intraoperative Pyeloplasty Stent Set	Aug 28, 2017	Substantially Equivalent	Cook Incorporated
K163399	Tria Firm Ureteral Stent	Jun 22, 2017	Substantially Equivalent	Boston Scientific Corporation
K162109	Kwart Retro-Inject Ureteral Stent	Jun 07, 2017	Substantially Equivalent	Cook Incorporated
K162104	C-Flex Ureteral Stent Set	Apr 24, 2017	Unknown	Cook Incorporated
K161236	Universa Firm Ureteral Stents and Stent Sets	Jan 27, 2017	Substantially Equivalent	Cook Incorporated
K163068	pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent	Dec 22, 2016	Substantially Equivalent	Q Urological Corporation
K161277	ConvertX Nephroureteral Stent System	Nov 22, 2016	Substantially Equivalent	Brightwater Medical
K160891	Ultrathane Endoureterotomy Stent Set	Jun 24, 2016	Substantially Equivalent	Cook Incorporated
K151051	Universa Soft Ureteral Stents and Stent Sets	Jan 11, 2016	Substantially Equivalent	Cook Incorporated
K141344	EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM	Oct 17, 2014	Substantially Equivalent	Boston Scientific Corp
K082805	PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX	Jan 20, 2010	Substantially Equivalent	Q Urological Corporation
K072293	FOSSA URETERAL OPEN STENTS	Aug 06, 2008	Substantially Equivalent	Fossa Medical, Inc.
K063742	RESONANCE METALLIC URETERAL STENT	May 08, 2007	Substantially Equivalent	Cook Ireland, Ltd.
K060673	PEDIATRIC URETERAL STENT	Mar 29, 2006	Substantially Equivalent	Applied Medical Resources Corp.
K033210	BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET	Dec 30, 2004	Substantially Equivalent	Bioteque Corp.
K043193	BARD INLAYOPTIMA URETERAL STENT WITH SUTURE	Dec 07, 2004	Substantially Equivalent	C.R. Bard, Inc.
K040760	MODIFICATION TO URETERAL STENT	Oct 15, 2004	Substantially Equivalent	Applied Medical Resources Corp.
K031292	MODIFICATION TO FOSSA URETERAL STONE SWEEPER	May 22, 2003	Substantially Equivalent	Fossa Medical, Inc.
K030503	MODIFICATION TO CONTOUR POLARIS URETERAL STENT	Mar 17, 2003	Substantially Equivalent	Boston Scientific Corp
K022447	BARD ER URETERAL STENT WITH SUTURE	Jan 23, 2003	Substantially Equivalent	C.R. Bard, Inc.
K013921	PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X	Oct 17, 2002	Substantially Equivalent	Porges S.A.
K013784	URETERAL STENT	Aug 08, 2002	Substantially Equivalent	Boston Scientific Corp
K021602	FOSSA URETERAL STONE SWEEPER	Jul 26, 2002	Substantially Equivalent	Fossa Industries, Inc.
K021140	FOSSA EXPANDING DOUBLE PIGTAIL URETERAL STENT	Jun 28, 2002	Substantially Equivalent	Fossa Industries, Inc.
K011264	MESH URETERAL STENT	Jul 17, 2001	Substantially Equivalent	Applied Medical Resources Corp.
K010002	CONTOUR POLARIS URETERAL STENT	Jan 22, 2001	Substantially Equivalent	Boston Scientific Corp
K992391	UROSURGE SPIRALFLO URETERAL STENT	Aug 18, 1999	Substantially Equivalent	Urosurge, Inc.
K982974	DD URETERAL STENT, INTEGRAL STENT	Jul 02, 1999	Substantially Equivalent	Rusch Intl.
K991219	C-FLEX URETERAL STENTS	Jun 21, 1999	Substantially Equivalent	Applied Medical Resources
K983498	BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER REFERRED TO AS BARD LUBRICIOUS URETERAL STE	Dec 15, 1998	Substantially Equivalent	C.R. Bard, Inc.
K981591	VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT	Oct 09, 1998	Substantially Equivalent	International Regulatory Consultants
K981491	UROSURGE FILASTENT URETERAL STENT	May 29, 1998	Substantially Equivalent	Urosurge, Inc.
K981489	UROSURGE SPIRASTENT PLUS URETERAL STENT	May 29, 1998	Substantially Equivalent	Urosurge, Inc.
K974541	MODIFIED URETERAL INDWELLING CATHETER/STENT	Feb 09, 1998	Substantially Equivalent	Boston Scientific Corp
K973504	UROSURGE UROSTENT	Jan 30, 1998	Substantially Equivalent	Princeton Regulatory Assoc.
K961371	SUBCUTANEOUS URINARY DIVERSON STENT SET	Jul 24, 1996	Substantially Equivalent	Cook Urological, Inc.
K952513	LESE STENTS SETS	Jun 10, 1996	Substantially Equivalent	Cook Urological, Inc.
K961446	AQ HYDROPHILIC STENT	May 28, 1996	Substantially Equivalent	Cook Urological, Inc.
K960148	CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENT	Mar 25, 1996	Substantially Equivalent	Cabot Medical Corp.
K946296	QUADRA-COIL URETERAL STENT	Mar 06, 1995	Substantially Equivalent	Surgitek
K930731	SLIP-COAT STENTS	Dec 08, 1994	Substantially Equivalent	Cook Urological, Inc.
K941952	SURGITEK INFUSER	May 24, 1994	Substantially Equivalent	Surgitek
K933941	MENLO CARE URINARY DIVERSION STENT	Mar 31, 1994	Substantially Equivalent	Menlo Care, Inc.
K923394	MENLO CARE AQUASTENT SET	Nov 16, 1993	Substantially Equivalent	Menlo Care, Inc.
K930733	URETERAL STENT	Jul 23, 1993	Substantially Equivalent	Surgitek
K930882	UROLOGICAL CATHETER & ACCESSORIES	Jul 08, 1993	Substantially Equivalent	Applied Medical Resources
K925282	UROLOGICAL CATHETER AND ACCESSORIES	Jan 13, 1993	Substantially Equivalent	Applied Urology, Inc.
K920695	URETERAL STENT	Sep 23, 1992	Substantially Equivalent	Applied Urology, Inc.
K914280	ECHOSIGHT STENT SET	Jan 09, 1992	Substantially Equivalent	Cook Urological, Inc.
K913928	SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT	Nov 19, 1991	Substantially Equivalent	Surgitek Medical Engineering Corp.
K912060	MENTOR BLACK LIGHT INJECTION STENT SET	Sep 27, 1991	Substantially Equivalent	Mentor Corp.
K910691	NORTEC URETERAL STENT	Aug 15, 1991	Substantially Equivalent	North American Sterilization & Packaging Co.
K903345	BARD (R) LUBRICIOUS - COATED URETERAL STENT SUTURE	Apr 30, 1991	Substantially Equivalent	C.R. Bard, Inc.
K905505	VAS-CATH URETERAL STENTS CATHETER, MODIFICATION	Apr 09, 1991	Substantially Equivalent	Vas-Cath, Inc.
K905289	SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT	Mar 13, 1991	Substantially Equivalent	Medical Engineering Corp.
K904231	MODEL OSP, SANDHILL AMS	Jan 02, 1991	Substantially Equivalent	Sandhill Scientific, Inc.
K894357	VAS-CATH URETERAL STENT CATHETER	Oct 03, 1989	Substantially Equivalent	Vas-Cath, Inc.
K883561	BARD(R) URETERAL STENT W/SUTURE	Nov 15, 1988	Substantially Equivalent	C.R. Bard, Inc.
K882157	PANAMEX(TM) URETERAL STENT	Aug 02, 1988	Substantially Equivalent	Kingston Technologies, Inc.
K881744	PORGES URETERAL STENT	May 03, 1988	Substantially Equivalent	Bivona Medical Technologies
K880660	SURGITEK SUPER DOUBLE J URETERAL STENT KIT	Apr 14, 1988	Substantially Equivalent	Surgitek
K875038	MENTOR UNISTENT URETERAL STENT SET	Mar 03, 1988	Substantially Equivalent	Mentor Corp.
K873557	MENTOR BLACK LIGHT URETERAL STENT SET	Feb 11, 1988	Substantially Equivalent	Mentor Corp.
K872353	SURGITEK INFUSION STENT SYSTEM*	Sep 16, 1987	Substantially Equivalent	Surgitek
K871667	URETERAL STENT	Jun 10, 1987	Substantially Equivalent	Penn Medical Devices, Inc.
K871291	AM CATH ESWL STENT	Apr 30, 1987	Substantially Equivalent	Inter-Med Corp.
K865085	KAMINSKY COMBINATION STENT & INJECTION CATHETER	Mar 25, 1987	Substantially Equivalent	Van-Tec, Inc.
K864225	ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT	Jan 30, 1987	Substantially Equivalent	Angiomed U.S., Inc.
K864669	AM CATH ESWL STENT	Jan 05, 1987	Substantially Equivalent	Inter-Med Corp.
K863492	METAL TIPPED URETER. STENT & MAGNETIC STENT RETRI.	Dec 18, 1986	Substantially Equivalent	Surgitek
K862539	SILICONE DOUBLE COIL URETERAL STENT WITH SUTURE	Sep 09, 1986	Substantially Equivalent	Mentor Corp.
K861478	BARD DOUBLE PIGTAIL URETERAL STENT	May 15, 1986	Substantially Equivalent	C.R. Bard, Inc.
K860267	MARDIS DANGLER URETERAL STENT SET	Apr 03, 1986	Substantially Equivalent	Van-Tec, Inc.
K854908	UROFLEX	Mar 14, 1986	Substantially Equivalent	Angiomed U.S., Inc.
K860055	MENTOR SINGLE COIL URINARY DIVERSION STENT SET	Mar 11, 1986	Substantially Equivalent	Mentor Corp.
K854862	CURITY URETERAL STENT	Feb 10, 1986	Substantially Equivalent	The Kendal Co.
K852389	URETERAL STENT	Sep 05, 1985	Substantially Equivalent	American Medical Systems, Inc.
K851870	MENTOR UNIVERSAL URETERAL STENT SET	Jul 02, 1985	Substantially Equivalent	Mentor Corp.
K850175	MENTOR DBL-COIL INDWELL. SILICONE URETERAL STENT S	Mar 07, 1985	Substantially Equivalent	Mentor Corp.
K850176	MENTOR DBL-COIL INDWELLING POLYURETHANE URETERAL-	Feb 28, 1985	Substantially Equivalent	Mentor Corp.
K833782	SURGITEK ALL SILICONE INFECTION DOUBJ	Apr 02, 1984	Substantially Equivalent	Surgitek
K834401	URETERAL DOUBLE PIGTAIL STENT	Mar 22, 1984	Substantially Equivalent	Hobbs Medical, Inc.
K840059	SILITEK URINARY DIVERSION STENT	Feb 04, 1984	Substantially Equivalent	Surgitek
K832915	URETHRAL OBSTRUCT PRIMARY EXCHANGE STEN	Oct 14, 1983	Substantially Equivalent	Surgitek
K831857	SURGITEK PERCUTANEOUS ARNEGRADE SILITEK	Aug 11, 1983	Substantially Equivalent	Medical Engineering Corp.
K831446	SURGITEK NEPHROSTENT KIT	Jun 22, 1983	Substantially Equivalent	Mec/Surgitek Products
K823487	BARD URETERAL STENT	May 27, 1983	Substantially Equivalent	C.R. Bard, Inc.
K830884	SURGITEKS PERCUTANEOUS ANTEGRADE ALL -	May 09, 1983	Substantially Equivalent	Medical Engineering Corp.
K820870	URETERAL STANT SET	Apr 26, 1982	Substantially Equivalent	Van-Tec, Inc.
K800109	SURGITEK URINARY DIVERSION STENT	Feb 26, 1980	Substantially Equivalent	Medical Engineering Corp.
K781641	SURGITEK DOUBLE J URETEROL STENT	Dec 07, 1978	Substantially Equivalent	Medical Engineering Corp.