Product Code: KOD FDA class 2 21 CFR 876.5130

Catheter, Urological

Gastroenterology, Urology

A Urological Catheter is a flexible tube inserted into the urinary bladder through the urethra to drain urine, instill medications, or perform urological procedures in patients with urinary retention, obstruction, or incontinence. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket notification. The product code is KOD and the applicable regulation is 21 CFR 876.5130 in the Gastroenterology and Urology specialty. This device is eligible for third-party review.

View on FDA

510(k)s

238

FEI Numbers

114

Registration Numbers

114

Unique Applicants

120

Years Active

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Basic Information

Product Code: KOD
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 238 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251864	Rubber Utility Catheter	Feb 23, 2026	Substantially Equivalent	C.R. Bard, Inc.
K220036	Wellead Ureteral Catheter	Dec 16, 2022	Substantially Equivalent	Well Lead Medical Co., Ltd.
K220730	allFlex Ureteral Catheters, Krait Ureteral Catheters	Oct 13, 2022	Substantially Equivalent	Allwin Medical Devices, Inc.
K211032	Urinary Catheter 12 Fr, Urinary Catheter 16 Fr	Nov 19, 2021	Substantially Equivalent	Urogen Pharma, Ltd.
K181979	Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter	May 24, 2019	Substantially Equivalent	Teleflexmedical, Inc.
K180354	UroGen Ureteral Catheter	Oct 30, 2018	Substantially Equivalent	Urogen Pharma, Ltd.
K181144	Angled Tip Ureteral Catheter	Jun 28, 2018	Substantially Equivalent	Cook Incorporated
K180530	Imager II Urology Torque Catheter	Apr 10, 2018	Substantially Equivalent	Boston Scientific Corporation
K171810	Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter	Mar 07, 2018	Substantially Equivalent	Cook Incorporated
K171600	Renal Access Cobra Catheter, Kumpe Access Catheter	Feb 16, 2018	Substantially Equivalent	Cook Incorporated
K171662	Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter	Feb 01, 2018	Substantially Equivalent	Cook Incorporated
K172924	GentleCath Intermittent Urinary Catheter	Nov 21, 2017	Substantially Equivalent	Convatec Limited
K161344	GentleCath Glide Intermittent Catheter	Sep 20, 2016	Substantially Equivalent	Convatec Limited
K160877	United Urologics Closed System Catheter	May 20, 2016	Substantially Equivalent	Robling Medical, Inc.
K140953	GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER	Aug 01, 2014	Substantially Equivalent	Convatec, Ltd.
K110491	BACKSTOP CATHETER	Mar 16, 2011	Substantially Equivalent	Pluromed, Inc.
K103349	BACKSTOP CATHETER	Jan 07, 2011	Substantially Equivalent	Pluromed, Inc.
K102527	IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C2 TIP; IMAGER II UROLOGY TORQUE CATHETER	Nov 05, 2010	Substantially Equivalent	Boston Scientific Corporation
K090270	BACKSTOP CATHETER, MODEL 60-0000-3100	May 15, 2009	Substantially Equivalent	Pluromed, Inc.
K080878	MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT)	Jul 17, 2008	Substantially Equivalent	Medical Technologies of Georgia, Inc.
K080881	CURE CATHETER CLOSED SYSTEM	Jun 11, 2008	Substantially Equivalent	Cure Medical, LLC
K040897	DOVER ROB-NEL CATHETER	Jul 20, 2004	Substantially Equivalent	Tyco Healthcare
K041243	DOVER RED RUBBER ROBINSON CATHETER	Jul 07, 2004	Substantially Equivalent	Tyco Healthcare
K033719	BARD TIGERTAIL URETERAL CATHETER	Feb 04, 2004	Substantially Equivalent	C.R. Bard, Inc.
K032710	CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT	Jan 09, 2004	Substantially Equivalent	Apogee Medical, Inc.
K033023	INTERMITTENT URETHRAL CATHETERS	Dec 23, 2003	Substantially Equivalent	Rusch Intl.
K022135	URETERAL ACCESS SHEATH SET (UASS)	Sep 13, 2002	Substantially Equivalent	Boston Scientific Corp
K013483	INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT	Jan 14, 2002	Substantially Equivalent	Hollister, Inc.
K013345	INCARE INTERMITTENT CATHETER	Jan 07, 2002	Substantially Equivalent	Hollister, Inc.
K011965	IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1	Jul 13, 2001	Substantially Equivalent	Boston Scientific Corp
K010339	ENDOCARE PERCUTANEOUS ACCESS SET	Mar 07, 2001	Substantially Equivalent	Endocare, Inc.
K002396	ENDOCARE PERCUTANEOUS ACCESS SET	Oct 13, 2000	Substantially Equivalent	Endocare, Inc.
K001583	ISLAND BIOSURGICAL BNS KIT #3	Jul 13, 2000	Substantially Equivalent	Island Biosurgical, LLC
K000723	HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)	May 19, 2000	Substantially Equivalent	Rochester Medical Corp.
K000070	FLOCATH	Feb 18, 2000	Substantially Equivalent	Rusch Intl.
K965229	IMAGER TORQUE CATHETER	Mar 04, 1997	Substantially Equivalent	Boston Scientific Corp
K951260	URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT	Sep 27, 1995	Substantially Equivalent	Biosearch Medical Products, Inc.
K945061	NOPROFILE OLBERT CATHETER SYSTEM	Mar 09, 1995	Substantially Equivalent	Meadox Surgimed, Inc.
K922527	BARD URODYNAMIC CATHETERIZATION PROCEDURE TRAY	Apr 14, 1994	Unknown	C.R. Bard, Inc.
K933109	4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS	Mar 28, 1994	Unknown	Boston Pacific Medical, Inc.
K915459	FLOWMATE HAND PUMP	Feb 15, 1994	Substantially Equivalent	Psi Medical Products, Inc.
K931195	PERCUTANEOUS DRAINAGE LOOP CATHETER SET	Dec 22, 1993	Substantially Equivalent	Cook Urological, Inc.
K933400	KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMPERATURE SENSOR	Nov 15, 1993	Substantially Equivalent	Kendall Healthcare Products Co. Div.Of Tyco Health
K930608	ONIK-COHEN ACCESS SET	Jul 09, 1993	Substantially Equivalent	Cook Urological, Inc.
K923906	FOLEY INSERTION TRAY	Jun 22, 1993	Unknown	Kit Pak, Inc.
K922051	KIT PAK'S FLUSHING KIT	Jun 17, 1993	Unknown	Kit Pak, Inc.
K922431	BARD LATEX URINARY CATHETERS	Mar 25, 1993	Unknown	C.R. Bard, Inc.
K923607	RADIFOCUS GUIDE WIRE M	Oct 02, 1992	Substantially Equivalent	Terumo Medical Corp.
K921054	KENDALL MOD. PEDIATRIC ULTRAMER POLYURETHANE CATH.	Sep 23, 1992	Substantially Equivalent	Kendall Healthcare Products Co. Div.Of Tyco Health
K921415	IRRIGATION TUBING SET	Sep 04, 1992	Substantially Equivalent	Psi Medical Products, Inc.
K921253	INSTRUMENT IRRIGATION PUMP	Aug 06, 1992	Substantially Equivalent	Psi Medical Products, Inc.
K914933	HEART PACK III	Jan 31, 1992	Unknown	Westmark Hospital Supplies
K912851	NAUDE URETHRAL STENT	Jan 30, 1992	Substantially Equivalent	Cook Urological, Inc.
K911242	KENDALL PEDIATRIC ULTRAMER POLYURETHANE CATHETER	Apr 25, 1991	Substantially Equivalent	Kendall Healthcare Products Co. Div.Of Tyco Health
K900509	NORTA SILICONE ELASTOMER COATED LATEX BALLOON CATH	Dec 14, 1990	Substantially Equivalent	Medical Latex Corp.
K904734	PHARMASEAL DISPOSABLE ABDOMINAL TROCAR	Nov 21, 1990	Substantially Equivalent	Baxter Healthcare Corp
K896729	NELATON-, FEMALE - OR TIEMANN CATHETER	Nov 05, 1990	Substantially Equivalent	Unoplast A/S
K896750	LOFRIC(R), LOFRIC(R) CATH-KIT	Aug 06, 1990	Substantially Equivalent	Astra Meditec AB
K901738	SELFCATH	Jun 27, 1990	Substantially Equivalent	Vitaid, Ltd.
K900229	BARD CONFORMACATH FOLEY CATHETER	Apr 17, 1990	Substantially Equivalent	C.R. Bard, Inc.
K900022	BJ STAR ALL SILICONE FOLEY BALLOON CATHETER	Mar 15, 1990	Substantially Equivalent	B.J. Star, Inc.
K896726	4 SURE EXTERNAL MALE CATHETER	Feb 26, 1990	Substantially Equivalent	The Boston & Pacific Co., Inc.
K896784	DISPOSABLE URODYNAMIC CATHETER SET	Feb 16, 1990	Substantially Equivalent	Life-Tech Intl., Inc.
K896725	4 SURE UROLOGICAL CATHETER	Feb 16, 1990	Substantially Equivalent	The Boston & Pacific Co., Inc.
K896053	ALL SILICONE FOLEY CATHETER	Feb 12, 1990	Substantially Equivalent	Rochester Medical Corp.
K895548	CONVEEN INTERMITTENT CATHETERS	Feb 09, 1990	Substantially Equivalent	Coloplast A/S
K896385	URETERAL ACCESS SET	Jan 22, 1990	Substantially Equivalent	Applied Urology, Inc.
K896213	Y-TYPE TUR/CONTINUOUS BLADDER IRRIGATION SET	Jan 18, 1990	Substantially Equivalent	Westmark, Sterile Packing Systems, Inc. (Sps)
K896211	CYSTOSCOPY/IRRIGATION SET	Jan 18, 1990	Substantially Equivalent	Westmark, Sterile Packing Systems, Inc. (Sps)
K896208	CYSTO PUMP DRAINAGE BAG	Jan 18, 1990	Substantially Equivalent	Westmark, Sterile Packing Systems, Inc. (Sps)
K890400	MODIFIED URINARY CATHETER INTRODUCER (UCI)	Sep 12, 1989	Substantially Equivalent	Go Medical Industries Pty. , Ltd.
K893390	MODIFIED PRISTINE CULTURE CATHETER	Sep 07, 1989	Substantially Equivalent	Hml Medical, Inc.
K892436	KENDALL CURITY IRRIGATION SYRINGE	Jul 14, 1989	Substantially Equivalent	The Kendal Co.
K892691	CATHETERS, MALE, FEMALE	Jun 23, 1989	Substantially Equivalent	Zinnanti Surgical Instruments, Inc.
K885202	16 LONG CATHETER W/ADAPTER, 14 FR AND 12 FR	Jan 31, 1989	Substantially Equivalent	Coeur Laboratories, Inc.
K883763	ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATH	Nov 18, 1988	Substantially Equivalent	Acme-Monaco Corp.
K881981	ASSIST(TM) ASEPTIC SYRINGE IRRIGATION SYSTEM	Aug 02, 1988	Substantially Equivalent	Ryder Intl. Corp.
K881781	CATHETER STRAP	Aug 02, 1988	Substantially Equivalent	Baxter Healthcare Corp
K881363	SYRINGE PREFILLED WITH WATER	Jun 23, 1988	Substantially Equivalent	I M, Inc.
K881646	UROLOGICAL CATHETER	Jun 16, 1988	Substantially Equivalent	Coeur Laboratories, Inc.
K880100	COOK UROLOGICAL WIRE GUIDE W/HYDROMER COATING	Mar 15, 1988	Substantially Equivalent	Cook Urological, Inc.
K875383	LAKE CATHETER CARE KITS (MODIFICATION)	Mar 09, 1988	Unknown	Lake Medical Products, Inc.
K874112	VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER	Feb 11, 1988	Substantially Equivalent	Van-Tec, Inc.
K874682	MMG CATHETER PLUG W/DRAINAGE TUBE COVER	Jan 27, 1988	Substantially Equivalent	Medical Marketing Group
K874525	MODIFIED FOLEY CATHETER/TEMPERATURE SENSOR	Jan 06, 1988	Substantially Equivalent	Mon-A-Therm, Inc.
K874312	ACKRAD RETROGRADE URETHROGRAPHY SET	Dec 29, 1987	Substantially Equivalent	Ackrad Laboratories
K874293	ACKRAD V/CUG VOIDING CYSTOURETHROGRAPHY SET	Dec 29, 1987	Substantially Equivalent	Ackrad Laboratories
K873448	FOLEY CATHETER TEMPERATURE SENSOR	Dec 07, 1987	Substantially Equivalent	Respiratory Support Products, Inc.
K874517	PHARMASEAL RUBBER URETHRAL CATHETER	Dec 03, 1987	Substantially Equivalent	American Pharmaseal Div. Ahsc
K873287	IRRIGATION TRAY (W/120CC OF STERILE NORMAL SALINE)	Nov 13, 1987	Unknown	Todd Medical, Inc.
K873435	LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET	Oct 05, 1987	Substantially Equivalent	Level 1 Technologies, Inc.
K872750	LAKE CATHETER CARE KIT	Sep 03, 1987	Substantially Equivalent	Lake Medical Products, Inc.
K871429	ANTIMICROBIAL FOLEY CATHETER	Aug 10, 1987	Substantially Equivalent	American Pharmaseal Div. Ahsc
K864592	JUDD URETHAL CATHETER CONTAINER	Jun 24, 1987	Substantially Equivalent	Phil Judd, Inc.
K870165	FOLEY CATHETER	Apr 17, 1987	Substantially Equivalent	Acorn Medical Products
K871297	KADIR HI-TORQUE GUIDE WIRE	Apr 10, 1987	Substantially Equivalent	Argon Medical Corp.
K870977	PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE	Apr 01, 1987	Substantially Equivalent	American Pharmaseal Div. Ahsc
K870557	VAN-TEC PUMPING SYSTEM	Mar 30, 1987	Substantially Equivalent	Van-Tec, Inc.
K870694	VAN-TEC OPEN ENDED CONE TIP URETERAL CATHETER	Mar 10, 1987	Substantially Equivalent	Van-Tec, Inc.
K864736	AKRO-SIL PLUS	Dec 24, 1986	Substantially Equivalent	Akron Catheter, Inc.
K861699	CATHETER VALVES KV 100 & KV 100EH	Nov 19, 1986	Substantially Equivalent	Max Staubli , Ltd.
K862098	PRISTINE/BLOOMING/PRISTINE BLOOMING CULTURE CATH	Nov 12, 1986	Substantially Equivalent	Hall/Mccollum Laboratories, Inc.
K863082	COOK-VPI INTERMITTENT CATHETER	Nov 07, 1986	Substantially Equivalent	Cook Urological, Inc.
K863958	TUBEGRIPPER, UROLOGICAL CATHETER & ACCESSORY	Nov 04, 1986	Substantially Equivalent	Cathaid, Inc.
K863354	BIO-GUARD AB COATED CATHETER	Nov 04, 1986	Substantially Equivalent	Cook Urological, Inc.
K863517	FOLEY CATHETERS	Oct 31, 1986	Substantially Equivalent	Instrumentation Industries, Inc.
K863282	CARE + PLUS CATHETER CARE TRAY	Oct 31, 1986	Substantially Equivalent	Welmed Systems, Inc.
K863281	CARE + PLUS IRREGATION TRAY	Oct 31, 1986	Substantially Equivalent	Welmed Systems, Inc.
K863302	MODIFIED FOLEY CATHETER	Oct 03, 1986	Substantially Equivalent	Sheridan Catheter Corp.
K862484	HCI Y-CONNECTOR	Sep 09, 1986	Substantially Equivalent	Hospital Concepts, Inc.
K860325	PRISTINE CULTURE CATHETER	Aug 19, 1986	Substantially Equivalent	Hall/Mccollum Laboratories, Inc.
K862124	POLYMED LABORATORIES ALL SILICONE FOLEY CATHETER	Aug 14, 1986	Substantially Equivalent	Polymed Laboratories
K861200	UROTOPO CATHETER	Apr 23, 1986	Substantially Equivalent	Houston Biomedical, Inc.
K861181	NORTA TEFLON COATED LATEX BALLOON CATHETERS	Apr 08, 1986	Substantially Equivalent	Beiersdorf, Inc.
K860265	TELESCOPE PROTECTION TUBE	Apr 07, 1986	Substantially Equivalent	R. J. Ltd., Ind.
K860337	VAN-TEC URETERAL ANESTHE. STONE DISPLACEMENT CATH.	Mar 25, 1986	Substantially Equivalent	Van-Tec, Inc.
K860484	CURITY & KENGUARD SILICONE COATED FOLEY CATHETER	Mar 11, 1986	Substantially Equivalent	The Kendal Co.
K855143	ANGIOMED EXCHANGE DRAINAGE CATHETER SETS	Mar 11, 1986	Substantially Equivalent	Angiomed U.S., Inc.
K855076	ANGIOMED URETER DIATION SETS	Mar 11, 1986	Substantially Equivalent	Angiomed U.S., Inc.
K854625	UROTEC CLOSED IRRIGATIION SYRINGE	Mar 04, 1986	Substantially Equivalent	Urotec Systems Corp.
K855140	ANGIOMED RENAL DILATION SET	Feb 24, 1986	Substantially Equivalent	Angiomed U.S., Inc.
K855077	ANGIOMED HARZMANN DISCS	Jan 21, 1986	Substantially Equivalent	Angiomed U.S., Inc.
K854443	O'NEIL URINARY CATHETER INTRODUCER	Jan 08, 1986	Substantially Equivalent	Pennine Medical , Ltd.
K852084	KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMP	Sep 20, 1985	Substantially Equivalent	The Kendal Co.
K853207	PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE	Sep 12, 1985	Substantially Equivalent	American Pharmaseal Div. Ahsc
K853337	TROCAR/CANNULA/SHEATH SET	Aug 23, 1985	Substantially Equivalent	American Edwards Laboratories
K851160	VAN-TEC GUIDE WIRE W/HYDROMER COATING	Jul 29, 1985	Substantially Equivalent	Van-Tec, Inc.
K851857	UROLOGICAL CATHETER & ACCESSORIES FOLEY CATHETER	Jul 15, 1985	Substantially Equivalent	Sheridan Catheter Corp.
K851684	UROTEC/FRANKLIN SOFT SIMPLASTIC CATHETER	Jul 02, 1985	Substantially Equivalent	Urotec Systems Corp.
K851180	IRRIGATION TRAY	Apr 25, 1985	Substantially Equivalent	Pace Pharmaceutical Services, Inc.
K851179	CATHETER CARE TRAY	Apr 25, 1985	Substantially Equivalent	Pace Pharmaceutical Services, Inc.
K850790	DIAFLEX OCCLUSION BALLOON CATHETER	Mar 25, 1985	Substantially Equivalent	American Edwards Laboratories
K850335	URETEROSCOPY CATHETER	Mar 12, 1985	Substantially Equivalent	Inmed Corp.
K850285	GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY	Feb 28, 1985	Substantially Equivalent	Premium Plastics, Inc.
K842420	NORTA SILICONIZED LATEX BALLOON CATH.	Nov 21, 1984	Substantially Equivalent	Beiersdorf, Inc.
K842866	URETHRAL CATHETERIZATION TRAY	Sep 10, 1984	Substantially Equivalent	Inmed Corp.
K842228	AIMED FOLEY CATHETER VARIOUS SIZES	Sep 10, 1984	Substantially Equivalent	Tech-Cons Ltd., Intl.
K842890	PERCUFIX CATHETER CUFF	Sep 04, 1984	Substantially Equivalent	Medi-Tech, Inc.
K841769	INTERMITTENT URETHRAL CATHETER TRAY	Aug 24, 1984	Substantially Equivalent	Seamless Hospital Products Co.
K841941	VAN-TEC OCCLUSION BALLOON CATHETER	Aug 08, 1984	Substantially Equivalent	Van-Tec, Inc.
K841819	CORPAK FOLEY CATH TRAY W/16FR. TEFLON	Jul 19, 1984	Substantially Equivalent	Corpak Co.
K841678	STERILE, FOLEY CATHETERS W/PTFE COAT	Jul 19, 1984	Substantially Equivalent	Abco Dealers, Inc.
K841511	HAEMATURIA CATHETERS	Jul 12, 1984	Substantially Equivalent	Warne Surgical Products, Ltd.
K841544	AMER. PHARMASEAL SILICONIZED LATEX	Jul 09, 1984	Substantially Equivalent	American Pharmaseal Div. Ahsc
K841727	UROLOGICAL CATHETER & ACCESSORIES	Jun 07, 1984	Substantially Equivalent	Research Medical, Inc.
K841485	UROLOGICAL KIT W/STERILE, WATER-FILL	May 09, 1984	Substantially Equivalent	Medline Industries, Inc.
K840839	MMG FOLEY CATHETER	Apr 17, 1984	Substantially Equivalent	Medical Technologies of Georgia
K832363	FOLEY CATHETERIZATION TRAY-VARIOUS	Mar 07, 1984	Substantially Equivalent	Inmed Corp.
K834438	TEMPERATURE SENSING FOLEY CATHETER	Feb 04, 1984	Substantially Equivalent	C.R. Bard, Inc.
K833719	PREPACELL THIN NEEDLE ASPIRATION TRAY	Jan 25, 1984	Substantially Equivalent	Applied Medical Devices, Inc.
K833432	CATHETER INSERTION KIT	Dec 28, 1983	Substantially Equivalent	Clinipad Corp.
K833790	CURITY 100% SILICONE COUDE' CATHETER	Dec 27, 1983	Substantially Equivalent	The Kendal Co.
K832389	CATHETER CARE TRAY	Sep 19, 1983	Substantially Equivalent	Inmed Corp.
K832692	CURITY CATHETER STRAP	Sep 12, 1983	Substantially Equivalent	The Kendal Co.
K831743	STERILE FOLEY CATHETERS & UROLOGICAL	Sep 12, 1983	Substantially Equivalent	Electromedics, Inc.
K831567	FOLEY-TEMP	Aug 10, 1983	Substantially Equivalent	Mallinckrodt Critical Care
K832165	IMPROVED SILICATH SILICONE ELASTOMER	Aug 08, 1983	Substantially Equivalent	Travenol Laboratories, S.A.
K831244	URETERAL STONE EXTRACTOR CATHETER	Jun 17, 1983	Substantially Equivalent	American Edwards Laboratories
K831369	LATEX URINARY CATHETERS	May 27, 1983	Substantially Equivalent	Wayne Surgical Products
K830359	STERILE CATHERIZATION PROCEDURE TRAYS	Mar 17, 1983	Substantially Equivalent	Welcon, Inc.
K830444	STERILE, ALL PURPOSE URETHRAL CATHETER	Mar 09, 1983	Substantially Equivalent	Abco Dealers, Inc.
K823818	CATHETER HOLDER	Jan 09, 1983	Substantially Equivalent	Danek Medical, Inc.
K821818	RETRIEVAL BALLOONS	Sep 24, 1982	Substantially Equivalent	American Endoscopy, Inc.
K821970	DYNACOR URETHRAL CATHETER TRAY	Jul 21, 1982	Substantially Equivalent	Medline Industries, Inc.
K821745	BARDEX ALL SILICONE PEDIATRIC CATHETER	Jun 24, 1982	Substantially Equivalent	C.R. Bard, Inc.
K821272	BN-74 COATED BARDEX ALL SILICONE CATH	Jun 22, 1982	Substantially Equivalent	C.R. Bard, Inc.
K820987	FOLEY INSERTION TRAYS W/OVERWRAY	May 13, 1982	Substantially Equivalent	Inmed Corp.
K820838	CURITY ECONOMY I CYSTOSCOPY	May 11, 1982	Substantially Equivalent	The Kendal Co.
K820868	URETERAL CATHETER CONNECTOR	Apr 26, 1982	Substantially Equivalent	Van-Tec, Inc.
K820866	URETERAL CATHETER CONNECTING TUBE	Apr 26, 1982	Substantially Equivalent	Van-Tec, Inc.
K820239	RETRIEVAL FORCEPS	Mar 26, 1982	Substantially Equivalent	American Endoscopy, Inc.
K820637	CATH-HOLD	Mar 25, 1982	Substantially Equivalent	Womco Products
K820419	AM. PH. STERILE SINGLE-USE URETHRAL CATH	Mar 23, 1982	Substantially Equivalent	American Pharmaseal Div. Ahsc
K820313	VPI-FAIR URETHRAL STENT	Mar 01, 1982	Substantially Equivalent	Vance Products, Inc.
K812995	VANCE-JACOBELLIS MICROHEMATURIA CATHETER	Mar 01, 1982	Substantially Equivalent	Vance Products, Inc.
K812887	ROBINSON CATHETERS NON-STERILE	Nov 17, 1981	Substantially Equivalent	Abco Dealers, Inc.
K811924	PRE-FILLED SYRINGE & CYSTOFLO URINARY BG	Nov 10, 1981	Substantially Equivalent	Travenol Laboratories, S.A.
K812281	TOUCHLESS HOME-CATH	Oct 13, 1981	Substantially Equivalent	Diamed Division Ill. Tool Works, Inc.
K811277	CATH-DAP	Jul 20, 1981	Substantially Equivalent	Northwest Alabama Urological Assoc.
K810690	CURITY 100% SILICONE SAFETY INDICATOR	Apr 23, 1981	Substantially Equivalent	The Kendal Co.
K810249	TRAY, CATHERIZATION, URETHRAL	Apr 07, 1981	Substantially Equivalent	Megaplast, Inc.
K810630	SILICONE ELASTOMER COATED LATEX FOLEY	Mar 31, 1981	Substantially Equivalent	G.D. Searle and Co.
K810372	VANCE DEFLECTABLE BIOPSY BRUSH SET	Mar 20, 1981	Substantially Equivalent	Vance Products, Inc.
K810367	KISH URETHRAL ILLUMINATED CATHETER SET	Mar 20, 1981	Substantially Equivalent	Vance Products, Inc.
K810281	UROLOGICAL CATHETERS	Feb 25, 1981	Substantially Equivalent	Latex Ind., Inc.
K810216	ARGYLE ROB-NELS	Feb 09, 1981	Substantially Equivalent	Sherwood Medical Co.
K803259	CLOSED SYSTEM URETHRAL CATHETERIZ. SET	Jan 09, 1981	Substantially Equivalent	Medical Devices, Inc.
K803062	CATH-SECURE	Jan 07, 1981	Substantially Equivalent	Melissa C. Johnson
K802878	K-KATH URETHRAL CATHETER INTRODUCER	Jan 02, 1981	Substantially Equivalent	B&K Medical
K803080	ALL PUPOSE URETHRAL CATHETER	Dec 22, 1980	Substantially Equivalent	American Hospital Supply Corp.
K803079	FOLEY CATHETER	Dec 22, 1980	Substantially Equivalent	American Hospital Supply Corp.
K802875	ARGYLE HEMATURIA BALLOON CATHETER	Dec 16, 1980	Substantially Equivalent	Sherwood Medical Co.
K802665	TOUCHLESS CLEAN-CATH	Nov 12, 1980	Substantially Equivalent	Diamed Division Ill. Tool Works, Inc.
K802516	FOLEY CATHETER	Oct 31, 1980	Substantially Equivalent	Abco Dealers, Inc.
K801820	FOLEY CATHETERIZATION TRAY	Oct 21, 1980	Substantially Equivalent	Abco Dealers, Inc.
K801787	URINARY CATHETER CARE TRAYS #3700&3710	Oct 21, 1980	Substantially Equivalent	The Healthcare Group Laboratories, Inc.
K801785	URETHRAL CATHETERIZATION TRAYS	Oct 21, 1980	Substantially Equivalent	The Healthcare Group Laboratories, Inc.
K801786	URINE COLLECTION CONTAINERS, #3600 &3610	Sep 30, 1980	Substantially Equivalent	The Healthcare Group Laboratories, Inc.
K802083	CATHETER INSERTION TRAY	Sep 16, 1980	Substantially Equivalent	Walpak Co.
K801415	LATEX FOLEY CATHETER (HYDROMER COATED)	Aug 20, 1980	Substantially Equivalent	G.D. Searle and Co.
K801784	URINARY CATHETERS #3400,3410 &3420	Aug 13, 1980	Substantially Equivalent	The Healthcare Group Laboratories, Inc.
K800609	CATHETER STYLET	Apr 10, 1980	Substantially Equivalent	G.D. Searle and Co.
K800505	URETHRAL CATHETER	Apr 08, 1980	Substantially Equivalent	Medi-Craft , Ltd.
K800308	PEDIATRIC FOLEY CATHETER	Feb 28, 1980	Substantially Equivalent	Abco Dealers, Inc.
K800307	IRRIGATION (3-WAY) FOLEY CATHETER	Feb 28, 1980	Substantially Equivalent	Abco Dealers, Inc.
K800306	FOLEY CATHETER	Feb 28, 1980	Substantially Equivalent	Abco Dealers, Inc.
K792719	3 WAY URETHRAL IRRIGATION CATHETER	Jan 16, 1980	Substantially Equivalent	Vesta, Inc.
K792220	VANCE KIDNEY BIOPSY BRUSHES	Dec 06, 1979	Substantially Equivalent	Vance Products, Inc.
K792111	CONPHAR SILICONE COATED FOLEY CATH	Nov 16, 1979	Substantially Equivalent	Conphar, Inc.
K792109	CONPHAR LATEX FOLEY CATH-STERILE	Nov 16, 1979	Substantially Equivalent	Conphar, Inc.
K792107	CONPHAR 100% SILICONE FOLEY CATH-STER.	Nov 16, 1979	Substantially Equivalent	Conphar, Inc.
K791598	CLOSED SYSTEM FOLEY CATHERIZATION PROCED	Nov 16, 1979	Substantially Equivalent	Walpak Co.
K792038	NELATON CATHETER	Nov 13, 1979	Substantially Equivalent	American Hospital Supply Corp.
K792037	NON-A-THERM	Nov 13, 1979	Substantially Equivalent	Labarge, Inc.
K791674	BLADDER RETENTION CATHETERIZATION TRAY	Nov 05, 1979	Substantially Equivalent	Latex Ind., Inc.
K791992	DYNACOR STERILE CARELON SILICONE CATH.	Oct 26, 1979	Substantially Equivalent	Medline Industries, Inc.
K791717	BARD URODYNAMIC CATHETERS	Sep 17, 1979	Substantially Equivalent	C.R. Bard, Inc.
K791427	CATHETERIZATION TRAYS FOLEY AND URETHRAL	Sep 07, 1979	Substantially Equivalent	Intermed, Inc.
K791244	CONPHAR FEMALE CATHETER-STERILE	Sep 07, 1979	Substantially Equivalent	Conphar, Inc.
K791332	UNIVERSAL FOLEY CATHETER TRAY	Aug 03, 1979	Substantially Equivalent	Abco Dealers, Inc.
K791264	CONPHAR NELATON CATHETER-STERILE	Aug 03, 1979	Substantially Equivalent	Conphar, Inc.
K790728	TOUCHLESS TM FOLEY CATHETER KIT	Jun 01, 1979	Substantially Equivalent	Diamed Division Ill. Tool Works, Inc.
K781751	CATHETER, AKRON FOLEY TEFLON	Jan 22, 1979	Substantially Equivalent	Latex Ind., Inc.
K781457	FOLEY CATHETERS	Sep 20, 1978	Substantially Equivalent	Intermed, Inc.
K760897	STERILE URETHRAL CATHETER KIT	Aug 31, 1978	Substantially Equivalent	Diamed Division Ill. Tool Works, Inc.
K780676	STERILE CLOSED SYSTEM	May 09, 1978	Substantially Equivalent	Medline Industries, Inc.
K780675	STERILE 100% SILICONE FOLEY CATHETER	May 09, 1978	Substantially Equivalent	Medline Industries, Inc.
K770814	CATHETER, URETHERAL	Oct 18, 1977	Substantially Equivalent	C.R. Bard, Inc.
K771779	CATHETERIZATION SYS. URINARY DRAINAGE	Oct 05, 1977	Substantially Equivalent	Medical Devices, Inc.
K770562	HANDLER CATHETER	Mar 24, 1977	Substantially Equivalent	Janet Beach, Ltd.
K770493	TRAVACATH	Mar 21, 1977	Substantially Equivalent	Travenol Laboratories, S.A.
K770489	CATHETER WITH HARD VALVE	Mar 21, 1977	Substantially Equivalent	Pharmaseal Div., Baxter Healthcare Corp.
K770256	CATHETERS, SILICONE COATED	Feb 17, 1977	Substantially Equivalent	Pharmaseal Div., Baxter Healthcare Corp.
K761144	FEM CATH (URETHRAL CATHETER)	Dec 06, 1976	Substantially Equivalent	Mallinckrodt Critical Care
K760858	RUTNER UNIVERSAL WEDGE CATHETER	Dec 06, 1976	Substantially Equivalent	Cook, Inc.
K761059	MALE URINARY CATHETER, EXTERNAL	Dec 02, 1976	Substantially Equivalent	Intermed, Inc.
K760440	CATHETER, NATURAL LATEX URETHRAL	Oct 20, 1976	Substantially Equivalent	Akron Catheter, Inc.
K760259	CATHETER 3-WAY SILICONE FOLEY	Aug 23, 1976	Substantially Equivalent	Travenol Laboratories, S.A.