Product Code: EYB FDA class 2 21 CFR 876.5130

Catheter, Ureteral, Gastro-Urology

Gastroenterology, Urology

The ureteral catheter for gastro-urology is a thin, flexible tube introduced through the cystoscope into the ureter and renal pelvis for urine drainage, contrast injection during pyelography, or access for therapeutic procedures such as stone retrieval. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is EYB, regulated under 21 CFR 876.5130 in the Gastroenterology, Urology specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: EYB
Device Class: FDA class 2
Regulation Number: 876.5130
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 28 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K192183	RocaTub Ureteral Catheter	Apr 23, 2020	Substantially Equivalent	Promepal Sam
K191187	Dornier MINNOW Ureteral Catheter	Sep 18, 2019	Substantially Equivalent	Dornier Medtech America, Inc.
K183323	UPJ Occlusion Balloon Catheter	Aug 05, 2019	Unknown	Cook Incorporated
K182695	Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter	Jun 17, 2019	Unknown	Cook Incorporated
K182122	Ureteric Catheters	Oct 04, 2018	Substantially Equivalent	Coloplast Corp.
K180182	Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter	Sep 14, 2018	Substantially Equivalent	Cook Incorporated
K171043	Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters	Dec 21, 2017	Substantially Equivalent	Coloplast Corp.
K133750	OCCLUDER OCCLUSION BALLOON CATHETER	Jan 08, 2014	Substantially Equivalent	Boston Scientific Corporation
K092250	MEDLINE RED RUBBER URETHRAL CATHETER	Jan 21, 2010	Substantially Equivalent	Medline Industries, Inc.
K083788	ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR	Mar 03, 2009	Substantially Equivalent	Endooptiks, Inc.
K043581	DUAL LUMEN CATHETER	Mar 03, 2005	Substantially Equivalent	Acmi Corporation
K030293	AMSURE RED RUBBER URETHRAL CATHETER	Feb 04, 2004	Substantially Equivalent	Amsino International, Inc.
K033368	FOSSA URETERAL OPEN LUMEN STENT	Nov 26, 2003	Substantially Equivalent	Fossa Medical, Inc.
K032521	BARD DUAL LUMEN URETERAL CATHETER	Nov 14, 2003	Substantially Equivalent	C.R. Bard, Inc.
K021856	PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX	Oct 17, 2002	Substantially Equivalent	Porges S.A.
K020577	APPLIED URETERAL CATHETER	May 22, 2002	Substantially Equivalent	Applied Medical Resources Corp.
K964899	KENDALL CURITY URETERAL CATHETER	Feb 07, 1997	Substantially Equivalent	Kendall Healthcare Products Co. Div.Of Tyco Health
K962004	AQ HYDROPHILIC UROLOGICAL CATHETERS	Jun 11, 1996	Substantially Equivalent	Cook Urological, Inc.
K950300	BARD FLEXIBLE TIP URETERAL CATHETER	Apr 27, 1995	Substantially Equivalent	C.R. Bard, Inc.
K941011	ACU-SIZER(TM)	Jun 13, 1994	Substantially Equivalent	Applied Medical Resources
K941012	LOW PRESSURE TAMPONADE BALLOON CATHETER	Apr 18, 1994	Substantially Equivalent	Applied Medical Resources
K941010	ACUCISE GUIDEWIRE EXCHANGE SHEATH	Apr 18, 1994	Substantially Equivalent	Applied Medical Resources
K933020	MOD. PHANTOM 5 PLUS UROL. BALLOON DILATION CATHETER	Jan 03, 1994	Substantially Equivalent	Boston Scientific Corp
K923729	URETERAL CATHETER	Dec 07, 1993	Substantially Equivalent	Cook Urological, Inc.
K930483	URETERAL CATHETER	Jul 16, 1993	Unknown	Surgitek
K921838	ACUCISE URETERAL CUTTING CATHETER	Feb 26, 1993	Substantially Equivalent	Applied Urology, Inc.
K914358	ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP	Nov 19, 1991	Substantially Equivalent	Hobbs Medical, Inc.
K882130	FOLEY-TEMP(TM)	Aug 09, 1988	Substantially Equivalent	Mallinckroot, Inc.