Product Code: EZN FDA class 2 21 CFR 876.5470

Dilator, Catheter, Ureteral

Gastroenterology, Urology

The Ureteral Catheter Dilator (product code EZN) is a medical instrument used to gradually widen the ureter to facilitate passage of catheters or to treat ureteral strictures. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.5470 in the Gastroenterology and Urology specialty. This device is eligible for third-party 510(k) review.

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FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: EZN
Device Class: FDA class 2
Regulation Number: 876.5470
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 56 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250910	Optilume® High Pressure Urological Balloon Dilation Catheter	May 22, 2025	Substantially Equivalent	Urotronic, Inc.
K220781	ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter	May 05, 2023	Substantially Equivalent	Allwin Medical Devices, Inc.
K201007	In-Ka Ureteral Balloon Dilatation Catheter	Jun 11, 2020	Unknown	Coloplast Corp.
K190612	EQUINOX Balloon Dilatation Catheter	Dec 06, 2019	Substantially Equivalent	Dornier Medtech America, Inc.
K173654	Ureteral Dilator Sets, Ureteral Dilators	Jul 17, 2018	Substantially Equivalent	Cook Incorporated
K180756	Safety Wire Guide Introducer	May 24, 2018	Substantially Equivalent	Cook Incorporated
K180028	Cook 810 Set, Desilets-Hoffman Introducer Set	May 02, 2018	Substantially Equivalent	Cook Incorporated
K172588	Balloon Catheter and Balloon Ureteral Dilator Set	Apr 19, 2018	Unknown	Cook Incorporated
K170531	Ureteral Dilators and Percutaneous Nephrostomy Dilators	Aug 17, 2017	Substantially Equivalent	Coloplast Corp.
K132181	GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER	Oct 21, 2013	Substantially Equivalent	Olympus Surgical Technologies America
K130804	UROMAX ULTRA BALLOON DILATATION CATHETER	May 22, 2013	Substantially Equivalent	Boston Scientific Corporation
K061009	PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS	May 02, 2006	Substantially Equivalent	Onset Medical Corporation
K050875	U-BALLOON DILATION CATHETER	May 26, 2005	Substantially Equivalent	C.R. Bard, Inc.
K043254	PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH	Feb 10, 2005	Substantially Equivalent	Onset Medical Corporation
K040127	COOK URETERAL BALLOON DILATION CATHETER SET	Apr 06, 2004	Unknown	Cook Urological, Inc.
K030662	PATHWAY ACCESS SHEATH CATHETER	Sep 03, 2003	Substantially Equivalent	Vertelink Corporation
K993840	BARD UROFORCE BALLOON DILATION CATHETER	Jan 31, 2000	Substantially Equivalent	C.R. Bard, Inc.
K990072	BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND BALLOON DILATION CATHETERS, BALLOON DILATION C	Mar 25, 1999	Substantially Equivalent	Cook Urological, Inc.
K980795	UROLOGICAL BALLOON DILATATION CATHETER	Apr 22, 1998	Substantially Equivalent	Boston Scientific Corp
K970041	ASCEND BALLOON DAILATION CATHETER	Mar 19, 1997	Substantially Equivalent	Cook Urological, Inc.
K962921	BARD A-TRAC UROLOGICAL BALLOON DILATION CATHETER	Oct 09, 1996	Substantially Equivalent	C.R. Bard, Inc.
K953691	MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING	Oct 16, 1995	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K953597	NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER	Oct 07, 1995	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K953004	DILATATION CATHETER, BALLOON	Sep 13, 1995	Substantially Equivalent	Boston Scientific Corp
K945576	MEADOX SURGIMED NOPROFILE(TM) OLBERT CATHETER SYSTEM(R)	Jan 24, 1995	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K941853	PASSPORT	Sep 12, 1994	Substantially Equivalent	Boston Scientific Corp
K942578	ENTRAC URETERAL BALLOON DILATATION CATHETERS	Aug 19, 1994	Substantially Equivalent	American Medical Systems, Inc.
K940542	NAMIC ARIA(TM) INFLATION DEVICE	Apr 18, 1994	Substantially Equivalent	American Medical Systems, Inc.
K935379	UROLOGICAL BALLOON DILATATION CATHETER	Feb 14, 1994	Substantially Equivalent	Boston Scientific Corp
K933011	MICROVASIVE UROLOGICAL BALLOON DILATION CATHETER	Feb 01, 1994	Substantially Equivalent	Boston Scientific Corp
K921839	ENTRAC URETERAL BALLOON DILATION CATHETERS	Oct 28, 1992	Substantially Equivalent	American Medical Systems, Inc.
K920946	UROLOGICAL BALLOON DILATATION CATHETER	Jul 01, 1992	Substantially Equivalent	Boston Scientific Corp
K915751	URETEROMAT 4400	Apr 24, 1992	Substantially Equivalent	F.M. Wiest USA, Inc.
K915392	ACCENT DG BALLOON URTERAL DILATOR SET, 10CM	Mar 18, 1992	Substantially Equivalent	Cook Urological, Inc.
K914617	CATHETER, URETERAL DILATOR	Dec 20, 1991	Substantially Equivalent	Boston Scientific Corp
K912331	URS-HYDRO-DILATOR MODEL NUMBER 2164.00	Oct 30, 1991	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K905375	ACCENT DG BALLOON URETERAL DILATOR SET	Apr 12, 1991	Substantially Equivalent	Cook Urological, Inc.
K905181	NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY	Mar 06, 1991	Substantially Equivalent	Meadox Surgimed, Inc.
K904983	MEADOX(R) SURGIMED OLBERT CATH SYST FOR UROLOGY	Jan 30, 1991	Substantially Equivalent	Meadox Surgimed, Inc.
K903813	URETERAL BALLOON DILATATION CATHETER	Nov 07, 1990	Substantially Equivalent	Boston Scientific Corp
K896448	BALLOON DILATION CATHETER	Mar 07, 1990	Substantially Equivalent	Cook Ob/Gyn
K894925	AMCATH URETERAL DILATORS MODELS 7100,7110,7120	Dec 13, 1989	Substantially Equivalent	Intec Medical, Inc.
K884711	URETHRAL AND URETERAL BALLOON DILATATORS	Sep 29, 1989	Substantially Equivalent	Primrose Medical, Inc.
K873178	URETERAL BULB DILATORS	Sep 30, 1987	Substantially Equivalent	Penn Medical Devices, Inc.
K870697	VAN-TEC ONE STEP URETERAL DILATATION CATHETER	Mar 10, 1987	Substantially Equivalent	Van-Tec, Inc.
K852324	URETERAL DILATOR	Aug 21, 1985	Substantially Equivalent	American Edwards Laboratories
K852793	URETERAL DILATOR/SHEATH SET	Aug 09, 1985	Substantially Equivalent	American Edwards Laboratories
K851463	OLBERT CATHETER SYS FOR URETERAL DILATION	May 23, 1985	Substantially Equivalent	Meadox Surgimed, Inc.
K851144	URETERAL DILATION SET	Apr 09, 1985	Substantially Equivalent	Van-Tec, Inc.
K850355	MENTOR PERCUTANEOUS RENAL DILATOR SET	Mar 12, 1985	Substantially Equivalent	Mentor Corp.
K842639	AMER. EDWARDS LAB DIAFLEX URETERAL DILA	Oct 02, 1984	Substantially Equivalent	American Edwards Laboratories
K842632	DILATOR/SHEATH SET	Oct 02, 1984	Substantially Equivalent	American Edwards Laboratories
K842206	DIAFLEX NEPHROSTOMY BALLOON DILATOR	Oct 02, 1984	Substantially Equivalent	American Edwards Laboratories
K841940	VAN-TEC URETERAL DILATION BALLOON CATH	Aug 03, 1984	Substantially Equivalent	Van-Tec, Inc.
K832808	URETERAL DILATION SET	Oct 14, 1983	Substantially Equivalent	Van-Tec, Inc.
K813278	VPI URETERAL DILATATION BALLON CATHETER	Dec 18, 1981	Substantially Equivalent	Vance Products, Inc.