Product Code: KOE FDA class 2 21 CFR 876.5520

Dilator, Urethral

Gastroenterology, Urology

A Urethral Dilator is a medical instrument used in urology to gradually widen the urethra in patients with urethral strictures or stenosis, restoring normal urinary flow and facilitating passage of other instruments during urological procedures. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket clearance. The product code is KOE and it is regulated under 21 CFR 876.5520 in the Gastroenterology and Urology specialty.

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510(k)s

FEI Numbers

Registration Numbers

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Years Active

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Basic Information

Product Code: KOE
Device Class: FDA class 2
Regulation Number: 876.5520
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 27 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K191061	Optilume Basic Urological Balloon Dilation Catheter	Jan 02, 2020	Substantially Equivalent	Urotronic, Inc.
K032840	ATRION MEDICAL QL INFLATION DEVICE	Mar 03, 2004	Substantially Equivalent	Atrion Medical Products, Inc.
K972964	ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE	Oct 10, 1997	Substantially Equivalent	Atrion Medical Products, Inc.
K962611	BARD EAGLE INFLATION DEVICE	Oct 21, 1996	Substantially Equivalent	Ryder Intl. Corp.
K961904	AQ HYDROPHILIC DILATORS	Oct 18, 1996	Substantially Equivalent	Cook Urological, Inc.
K924440	U.S. MEDICAL PS-7000 DIALYSIS SCALE	May 26, 1993	Substantially Equivalent	U.S. Medical Corp.
K920551	120 FR OPTILUME PROSTATE BALLOON DILATOR	Oct 28, 1992	Substantially Equivalent	American Medical Systems, Inc.
K922349	DOWD(TM) II	Aug 14, 1992	Substantially Equivalent	Boston Scientific Corp
K920711	ENTRAC URETHRAL BALLOON DILATATION CATHETER	May 06, 1992	Substantially Equivalent	American Medical Systems, Inc.
K913477	APEX(TM) PROSTATIC BALLOON DILATION CATHETER	Dec 27, 1991	Substantially Equivalent	Peripheral Systems Group
K902585	UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETER	Aug 27, 1990	Substantially Equivalent	Advanced Surgical Intervention, Inc.
K896713	ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS.	May 24, 1990	Substantially Equivalent	Advanced Surgical Intervention, Inc.
K900761	AMS OPTILUME(TM) PROSTATE BALLOON DILATOR	May 17, 1990	Substantially Equivalent	American Medical Systems, Inc.
K900760	AMS OPTILUME INFLATION SYRINGE	May 17, 1990	Substantially Equivalent	American Medical Systems, Inc.
K892855	URETHRAL BALLOON DILATION CATHETER SET	Nov 17, 1989	Substantially Equivalent	Cook Urological, Inc.
K873295	PROSTATIC URETHRO. BALLOON DILATATION CATHETER	Jul 31, 1989	Substantially Equivalent	Medi-Tech, Inc.
K873177	DEVINE (SUPRAPUBIC SOUND AND GUIDE)	Oct 14, 1987	Substantially Equivalent	Penn Medical Devices, Inc.
K870695	VAN-TEC URETHRAL DILATATION SYSTEM	Mar 10, 1987	Substantially Equivalent	Van-Tec, Inc.
K851158	VAN-TEC MEATAL DILATOR	Apr 15, 1985	Substantially Equivalent	Van-Tec, Inc.
K841386	KOLLMANN URETHRAL DILATOR	May 09, 1984	Substantially Equivalent	Imm Enterprises , Ltd.
K840746	URETERAL DILATOR	Apr 13, 1984	Substantially Equivalent	American Edwards Laboratories
K811833	VNACE FASCIAL DILATOR SET	Jul 10, 1981	Substantially Equivalent	Vance Products, Inc.
K810371	VANCE URETHAL DILATOR SET	Mar 20, 1981	Substantially Equivalent	Vance Products, Inc.
K800611	BOUGIE A BOULE	Apr 08, 1980	Substantially Equivalent	G.D. Searle and Co.
K800610	URETHRAL SOUND	Apr 08, 1980	Substantially Equivalent	G.D. Searle and Co.
K792221	VANCE PHILIPS FOLLOWER CATHETER & BOUGIE	Dec 06, 1979	Substantially Equivalent	Vance Products, Inc.
K792219	VANCE MALLEABLE TIP FILIFORM	Dec 06, 1979	Substantially Equivalent	Vance Products, Inc.