Product Code: KNX FDA class 2 21 CFR 876.5250

Collector, Urine, (And Accessories) For Indwelling Catheter

Gastroenterology, Urology

A Urine Collector with Accessories for Indwelling Catheter is a closed drainage system used in clinical settings to collect and contain urine from patients with indwelling urinary catheters, helping to maintain a sterile, closed circuit that reduces the risk of catheter-associated urinary tract infections. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket clearance. The product code is KNX and the applicable regulation is 21 CFR 876.5250 in the Gastroenterology and Urology specialty.

View on FDA

510(k)s

206

FEI Numbers

125

Registration Numbers

125

Unique Applicants

113

Years Active

Basic Information

Product Code: KNX
Device Class: FDA class 2
Regulation Number: 876.5250
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 4

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 206 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K110518	IBAG	Jun 24, 2011	Substantially Equivalent	FUTURE PATH MEDICAL, LLC
K973364	4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG	Mar 17, 1998	Substantially Equivalent	MAERSK MEDICAL A/S
K972887	MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG	Dec 11, 1997	Substantially Equivalent	MEDLINE INDUSTRIES, INC.
K971271	BESECURE EXTERNAL URINARY COLLECTION SYSTEM	Aug 18, 1997	Substantially Equivalent	UROLOGY RESEARCH INTL., INC.
K971929	AMSINO URINARY LEG BAG	Aug 06, 1997	Substantially Equivalent	AMSINO INTL., INC.
K971764	WELCON HUE-VU URINARY DRAINAGE BAG	Jul 29, 1997	Substantially Equivalent	WELCON, INC.
K964690	LIBERTY VALVE	Mar 21, 1997	Substantially Equivalent	CLEVELAND MEDICAL DEVICES, INC.
K964745	AMSINO URINARY DRAINAGE BAG	Mar 18, 1997	Substantially Equivalent	AMSINO INTL., INC.
K962652	URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)	Oct 04, 1996	Substantially Equivalent	CUSTOMED, INC.
K960949	PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167	Apr 19, 1996	Substantially Equivalent	BRISTOL-MYERS SQUIBB
K952208	PROSYS LEG BAG	Aug 15, 1995	Substantially Equivalent	CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
K944377	ORION'S URINARY DRAINAGE SET	Dec 06, 1994	Substantially Equivalent	REGULATORY & MARKETING SERVICES, INC.
K944236	NEEDLELESS URINE SAMPLING PORT	Nov 16, 1994	Substantially Equivalent	KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH
K940206	BARD URINE COLLECTION PRODUCTS MODIFICATION	Sep 16, 1994	Substantially Equivalent	C.R. BARD, INC.
K941447	SIMPLA S4, S5, S7	Jul 18, 1994	Substantially Equivalent	SIMPLA PLASTICS LTD.
K935557	URINARY DRAINAGE BAG	Mar 07, 1994	Substantially Equivalent	PURITAS HEALTH CARE, INC.
K931459	KENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBER	Jun 14, 1993	Substantially Equivalent	KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH
K925067	SIMPLA TRIDENT LEG BAG + SIMPLA S6 BAG	Jun 10, 1993	Substantially Equivalent	SIMPORT PLASTICS LTD
K926570	HOLLISTER(R) BEDSIDE DRAINAGE COLLECTION SYST 9878	May 21, 1993	Substantially Equivalent	HOLLISTER, INC.
K921024	URO-TOTE LEG BAG	Sep 02, 1992	Substantially Equivalent	NEOTECH PRODUCTS, INC.
K913142	BODEN WHEELCHAIR DRAINAGE SYSTEM	Sep 23, 1991	Substantially Equivalent	MNO MEDICAL PRODUCTS
K913223	STERILE DISPOSABLE URINE COLLECTOR & ACCESSORIES	Sep 04, 1991	Substantially Equivalent	MEDICAL DEVICE INSPECTION CO., INC.
K901320	ABSORBENT, DISPOSABLE URINARY DRAINAGE BAG	Jan 25, 1991	Substantially Equivalent	EP MEDICAL, INC.
K902417	BAG, URINE	Jul 16, 1990	Substantially Equivalent	GAINOR MEDICAL EUROPE, LTD.
K896688	URINE COLLECTOR LEG BAG	May 02, 1990	Substantially Equivalent	MEDLINE INDUSTRIES, INC.
K895168	URO-BAGGIE	Mar 22, 1990	Substantially Equivalent	CWT WORKSHOP
K896727	4 SURE URINARY DRAIN BAG	Feb 20, 1990	Substantially Equivalent	THE BOSTON & PACIFIC CO., INC.
K896579	GOOSEN URINARY DRAINAGE SYSTEM	Feb 15, 1990	Substantially Equivalent	GOOSEN ENTERPRISES, INC.
K895957	L.T.C. 1000 URINARY DRAINAGE BAG	Oct 24, 1989	Substantially Equivalent	INTL. MEDICAL MARKETING, INC.
K892437	KENDALL KENGUARD URINARY LEG BAGS	Jun 23, 1989	Substantially Equivalent	THE KENDAL CO.
K892433	KENDALL CURITY URINARY DRAINAGE BAGS	May 05, 1989	Substantially Equivalent	THE KENDAL CO.
K890551	URINARY DRAINAGE UNIT	Feb 28, 1989	Substantially Equivalent	CONSOLIDATED PRODUCTS & SERVICES, INC.
K890550	CP&S DISPOSABLE URINARY LEGBAG (MEDIUM & LARGE)	Feb 28, 1989	Substantially Equivalent	CONSOLIDATED PRODUCTS & SERVICES, INC.
K881678	SELF ADHESIVE URINARY EXTERNAL CATH. W/REMOVE. TIP	Aug 11, 1988	Substantially Equivalent	HOLLISTER, INC.
K881217	GENT-L-KARE STERILE URINARY LEG BAG	Jul 29, 1988	Substantially Equivalent	GENEVA LABORATORIES, INC.
K881213	GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER	Jul 28, 1988	Substantially Equivalent	GENEVA LABORATORIES, INC.
K880034	CLOSED URINARY DRAINAGE BAG W/ANTI-REFLUX & PORT	Mar 02, 1988	Substantially Equivalent	LIN-MARK, INC.
K874309	URETHAL CATHETER	Dec 07, 1987	Substantially Equivalent	MEDOVATIONS, INC.
K872824	P. URINE METER, 250CC	Oct 14, 1987	Substantially Equivalent	NI-MED, INC.
K873136	MMG CATH-N-PLACE	Sep 09, 1987	Substantially Equivalent	MEDICAL TECHNOLOGIES OF GEORGIA
K871643	CONVEEN(R) LEG-BAG (600 ML)	Jun 10, 1987	Substantially Equivalent	COLOPLAST A/S
K871610	CONVEEN(R) NIGHT DRAINAGE BAG (2000 ML)	Jun 10, 1987	Substantially Equivalent	COLOPLAST A/S
K871387	SECOND NATURE(TM)	May 29, 1987	Substantially Equivalent	ADVANCED CLINICAL PRODUCTS, INC.
K870504	NORTA (TM) UROBAG	Apr 01, 1987	Substantially Equivalent	BEIERSDORF, INC.
K871042	URINE METER, 250CC	Mar 25, 1987	Substantially Equivalent	SALT CREEK MEDICAL TECHNOLOGIES
K864188	E-Z HOLD WITH ADHESIVE BASE.-#4065	Dec 04, 1986	Substantially Equivalent	JOHN F. GREER CO., INC.
K863739	BESCURE	Oct 24, 1986	Substantially Equivalent	U-T, INC.
K863671	PENNINE LEG BAG 350ML CAT.NO.DB3 & 500ML.CAT.#DB5	Oct 03, 1986	Substantially Equivalent	SAMCO INDUSTRIES, INC.
K862581	NEPHROSTOMY CONNECTING TUBE (A-50)	Sep 23, 1986	Substantially Equivalent	ADVANCED CLINICAL PRODUCTS, INC.
K862580	NEPHROSTOMY DRAINAGE KIT (A-150)	Sep 23, 1986	Substantially Equivalent	ADVANCED CLINICAL PRODUCTS, INC.
K862251	MODIFIED BIO-FLOW MODEL 200 URINE FLOW DEVICE	Sep 04, 1986	Substantially Equivalent	BIO-FLOW, INC.
K862934	HOLLISTER FEMALE URINARY COLLECTION POUCH	Aug 19, 1986	Substantially Equivalent	HOLLISTER, INC.
K860362	SILICATH-AG SILICONE ELASTOMER FOLEY CATHETER	Apr 29, 1986	Substantially Equivalent	TRAVENOL LABORATORIES, S.A.
K854821	MMG EXTERNAL FEMALE CATHETERS	Apr 24, 1986	Substantially Equivalent	MEDICAL TECHNOLOGIES OF GEORGIA
K861192	GENTLE BACK, PLASTIC URINARY DRAINAGE BAG	Apr 23, 1986	Substantially Equivalent	ADVANCED CLINICAL PRODUCTS, INC.
K861251	AMP CLOSED URINARY DRAINAGE BAG, 1011 & 1011N	Apr 17, 1986	Substantially Equivalent	AMERICAN MEDICAL PRODUCTS, INC.
K855209	NIR LAT MALE EXTERNAL CATHETER	Jan 10, 1986	Substantially Equivalent	MALI, INC.
K854580	CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH	Dec 13, 1985	Substantially Equivalent	COLOPLAST A/S
K853892	VISTA MED-URISTAT	Dec 02, 1985	Substantially Equivalent	VISTA MED
K854480	URINARY DRAINAGE BAG	Nov 19, 1985	Substantially Equivalent	THE WEST CO., INC.
K852490	URI-CATH SYSTEM	Nov 05, 1985	Substantially Equivalent	GESCO INTL., INC.
K854173	UCD URINE SPECIMEN COLLECTOR	Nov 04, 1985	Substantially Equivalent	BAKER INSTRUCTIONS CORP.
K853458	H-H SEXTON SCUP URINE MGMT. SYS	Aug 27, 1985	Substantially Equivalent	HOLTER-HAUSNER INTL.
K852619	URI-SURE	Aug 27, 1985	Substantially Equivalent	ASHAI CO. LTD.
K852051	EXTERNAL MALE CATHETER	Aug 22, 1985	Substantially Equivalent	BUFFALO MEDICAL SPECIALTIES MFG., INC.
K852085	KENDALL CURITY URINARY OUTPUT MONITOR DRAINAGE BAG	Aug 07, 1985	Substantially Equivalent	THE KENDAL CO.
K844810	NEW BARD INFECTION CONTROL URINARY DRAINAGE BAG	Jul 24, 1985	Substantially Equivalent	C.R. BARD, INC.
K851681	SAFESTRETCH INCONTINENCE SYSTEM	Jun 28, 1985	Substantially Equivalent	DBT MEDICAL LTD.
K851266	QRI-FLOW URINE FLOW MEASURING DEVICE	Jun 27, 1985	Substantially Equivalent	BIO-FLOW, INC.
K851471	TRIBAG, TRIBAND & TRIFIX-REUSEABLE URINE COLLECTOR	Jun 12, 1985	Substantially Equivalent	LIC-ORTHION
K851470	BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR	Jun 12, 1985	Substantially Equivalent	LIC-ORTHION
K844155	STANDARD URINARY DRAINAGE BAG & LEG BAG	Jan 16, 1985	Substantially Equivalent	NORRIS W. WHITLOCK
K844801	ULTRA EXTERNAL CATHETER	Jan 15, 1985	Substantially Equivalent	INMED CORP.
K844684	COLOPLAST URO 2002 NIGHT DRAINAGE SYSTEM	Jan 08, 1985	Substantially Equivalent	COLOPLAST A/S
K843128	FEMALE URINARY INCONTINENCE SYS	Jan 02, 1985	Substantially Equivalent	CHESEBROUGH-POND'S U.S.A. CO.
K844280	TRAVENOL VALUE-LINE URINARY DRAINAGE BAG W/STERILE	Dec 17, 1984	Substantially Equivalent	TRAVENOL LABORATORIES, S.A.
K843698	CLOSED URINARY DRAINAGE UNIT	Dec 17, 1984	Substantially Equivalent	PATHFINDER INTL. CORP.
K843478	PHARMA-PLAST URIDROP-URIDOME	Dec 05, 1984	Substantially Equivalent	ZIMMAR CONSULTING LTD.
K843481	PHARMA-PLAST CONNECTING TUBE TYPE URIN-	Oct 18, 1984	Substantially Equivalent	ZIMMAR CONSULTING LTD.
K843480	PHARMA-PLAST URINARY DRAINAGE BAG 2000	Oct 11, 1984	Substantially Equivalent	ZIMMAR CONSULTING LTD.
K843479	PHARMA-PLAST LEG BAG	Oct 11, 1984	Substantially Equivalent	ZIMMAR CONSULTING LTD.
K843117	GREEN CROSS URINARY DRAINAGE BAG	Oct 11, 1984	Substantially Equivalent	TECH-CONS LTD., INTL.
K843126	MEDIFLEX DRAINAGE BAG	Oct 04, 1984	Substantially Equivalent	MEDIFLEX INTL.
K842397	URIHESIVE SYS MALE EXTERNAL CATHETER	Aug 08, 1984	Substantially Equivalent	CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
K842396	ACCUSEAL LEG BAGS & EXTENSION TUBES	Aug 08, 1984	Substantially Equivalent	CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
K842395	SUR-FIT NIGHT DRAINAGE CONTAINER SET	Aug 08, 1984	Substantially Equivalent	CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
K842257	CORPAK URINARY DRAINAGE BAG	Aug 08, 1984	Substantially Equivalent	CORPAK CO.
K832290	CYSTOFLO ANTIMICROBIAL URINARY DRAINAGE	Jul 31, 1984	Substantially Equivalent	TRAVENOL LABORATORIES, S.A.
K842553	CHESEBROUGH-POND'S REUSABLE URINARY LEG	Jul 20, 1984	Substantially Equivalent	CHESEBROUGH-POND'S U.S.A. CO.
K841197	CYSTO-AID	Jul 09, 1984	Substantially Equivalent	E-Z-EM, INC.
K841169	CURITY RIG FOLEY CATH TRAY	Jul 06, 1984	Substantially Equivalent	THE KENDAL CO.
K841224	URO-MALE INCONTINENCE CATHETER	May 02, 1984	Substantially Equivalent	GIL-MED INDUSTRIES C/O KEGAN & KEGAN, LTD.
K840917	URINARY MONITORING SYS 240	May 01, 1984	Substantially Equivalent	VITAL METRICS, INC.
K840284	MULTIPLE SYS-URINE DRAINAGE-CLOSED	Apr 13, 1984	Substantially Equivalent	LUTH CORP.
K840283	MULTIPLE BAG, LEG	Apr 13, 1984	Substantially Equivalent	LUTH CORP.
K840704	SECURE W/35MM DIAM, SHEATH/ADHESIVE	Mar 22, 1984	Substantially Equivalent	WARNE SURGICAL PRODUCTS, LTD.
K840703	SECURE W/30MM DIAM, SHEATH & ADHESIVE	Mar 22, 1984	Substantially Equivalent	WARNE SURGICAL PRODUCTS, LTD.
K840702	SECURE W/25MM DIAM. SHEATH & ADHESIVE	Mar 22, 1984	Substantially Equivalent	WARNE SURGICAL PRODUCTS, LTD.
K840292	URETHRAL CATH. TRAY W/BAG	Mar 16, 1984	Substantially Equivalent	CORPAK CO.
K834448	URINARY DRAINAGE CONTAINER	Feb 10, 1984	Substantially Equivalent	VITALMETRICS, INC.
K834337	URIHESIVE SYSTEM - IMPROVED	Feb 10, 1984	Substantially Equivalent	CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
K833570	COLOPLAST BABY URINE COLLECTORS	Jan 30, 1984	Substantially Equivalent	COLOPLAST A/S
K831530	PLASTIC LEG BAG	Jan 03, 1984	Substantially Equivalent	FOREVER-DRY, INC.
K833245	SECURITY STRETCH BRIEF-MEDICAL	Oct 31, 1983	Substantially Equivalent	MB PRODUCTS, LTD.
K832822	CLOSED SYS. DRAINAGE BAGS & TRAYS	Oct 14, 1983	Substantially Equivalent	MEDLINE INDUSTRIES, INC.
K832450	URO-TEX MALE EXTERNAL CATHETER	Oct 14, 1983	Substantially Equivalent	SIERRA LABORATORIES, INC.
K832526	UROTRACK PLUS	Sep 19, 1983	Substantially Equivalent	VITALMETRICS, INC.
K832537	CONVEEN LEG BAG W/TUBE-DRAINAGE BAG	Sep 12, 1983	Substantially Equivalent	TELCAM MEDICAL DEVICES, INC.
K831622	MORHEL CLOSED URINARY DRAINAGE SET	Aug 11, 1983	Substantially Equivalent	MORHEL MEXICANA
K831796	URINE BAG SYSTEM	Aug 08, 1983	Substantially Equivalent	I M, INC.
K832107	LEG BAG EXTENTION TUBE-STERILE	Jul 19, 1983	Substantially Equivalent	PLASCO, INC.
K832106	EXTERNAL INCONTINENCE CATHETER TRAVEL	Jul 19, 1983	Substantially Equivalent	PLASCO, INC.
K832109	EXTERNAL INCONTINENCE CATHETER TAKE-HOME	Jul 18, 1983	Substantially Equivalent	PLASCO, INC.
K832108	EXTERNAL INCONTINENCE CATHETER SET-NON	Jul 18, 1983	Substantially Equivalent	PLASCO, INC.
K831553	LEG DRAINAGE BAG STRAP BK6011	Jun 16, 1983	Substantially Equivalent	FRED SAMMONS, INC.
K831121	CURITY LEG BAG	Apr 28, 1983	Substantially Equivalent	THE KENDAL CO.
K830946	MALE EXTERNAL CATHETER	Apr 28, 1983	Substantially Equivalent	POST MEDICAL, INC.
K830192	MAC LEE UI URINE COLLECTION BAG	Feb 01, 1983	Substantially Equivalent	MAC LEE MEDICAL PRODUCTS
K823716	CYSTOFLO URINARY DRAINAGE BAG W/ANTIMIC	Jan 14, 1983	Substantially Equivalent	TRAVENOL LABORATORIES, S.A.
K823450	FEMALE EXTERNAL URINARY APPLIANCE	Dec 28, 1982	Substantially Equivalent	DIAMED DIVISION ILL. TOOL WORKS, INC.
K823411	PEDIATRIC URINE COLLECTOR	Dec 28, 1982	Substantially Equivalent	SAGE PRODUCTS, INC.
K822307	ADHESIVE SPRAY #4050-4060	Sep 24, 1982	Substantially Equivalent	THE HEALTHCARE GROUP LABORATORIES, INC.
K821979	STERILE FOLEY CATHETERIZATION KITS	Aug 30, 1982	Substantially Equivalent	MEDICAL DEVICES, INC.
K821978	STERILE URETHRAL CATHETERIZATION SET	Aug 25, 1982	Substantially Equivalent	MEDICAL DEVICES, INC.
K821848	ASSURE-MALE EXTERNAL INCONTINCE CATHETER	Aug 10, 1982	Substantially Equivalent	MEDICAL DESIGN & MANUFACTURING CORP.
K821829	UROGARD	Jul 30, 1982	Substantially Equivalent	BUCKMAN CONSULTANTS
K821854	U-200 BAG	Jul 22, 1982	Substantially Equivalent	MEDICAL TECHNOLOGIES OF GEORGIA
K821853	U-100 BAG	Jul 22, 1982	Substantially Equivalent	MEDICAL TECHNOLOGIES OF GEORGIA
K821168	DISPOSABLE URINARY LEGBAG W/STRAP	May 24, 1982	Substantially Equivalent	MEDICAL MARKETING GROUP
K821172	EXTERNAL FEMALE URINARY INCONTINENCE	May 10, 1982	Substantially Equivalent	THE HEALTHCARE GROUP LABORATORIES, INC.
K821171	URINARY COLLECTION CONTAINER/LEG BAG	May 10, 1982	Substantially Equivalent	THE HEALTHCARE GROUP LABORATORIES, INC.
K821161	EXTERNAL URINARY MALE INCONTINENCE DEV	May 10, 1982	Substantially Equivalent	THE HEALTHCARE GROUP LABORATORIES, INC.
K820565	MALE EXTERNAL CATHETER	Apr 01, 1982	Substantially Equivalent	UROCARE PRODUCTS, INC.
K813621	CURITY BEDSIDE DRAINAGE BAG	Feb 12, 1982	Substantially Equivalent	THE KENDAL CO.
K820234	HOLLISTER FEMALE URINARY COLLECT SYS	Feb 10, 1982	Substantially Equivalent	HOLLISTER, INC.
K820136	URINARY DRAINAGE BAG	Jan 29, 1982	Substantially Equivalent	MEGAPLAST, INC.
K813537	URIFIX	Jan 12, 1982	Substantially Equivalent	ISRAMED, INC.
K813479	ARGYLE PEDIATRIC URINE COLLECTOR	Jan 07, 1982	Substantially Equivalent	SHERWOOD MEDICAL CO.
K812907	FEMEX	Nov 02, 1981	Substantially Equivalent	PROMAC
K812249	SKIN ADHESIVE-50XX	Sep 23, 1981	Substantially Equivalent	MANFRED SAUER CORP.
K812294	CONVEEN URISHEATH & CONVEEN URILINER	Aug 31, 1981	Substantially Equivalent	TELCAM MEDICAL DEVICES, INC.
K812252	LATEX LEG BAG-57.XX	Aug 20, 1981	Substantially Equivalent	MANFRED SAUER CORP.
K812251	DISPOSABLE URINE GAB-70.XX	Aug 20, 1981	Substantially Equivalent	MANFRED SAUER CORP.
K812250	CONDOM-52.XX	Aug 20, 1981	Substantially Equivalent	MANFRED SAUER CORP.
K812058	AKRON URINARY DRAINAGE BAT	Jul 31, 1981	Substantially Equivalent	LATEX IND., INC.
K811469	MMG URINARY DRAINAGE TUBING	Jun 12, 1981	Substantially Equivalent	MEDICAL MARKETING GROUP
K810645	SELECT-A-FLOW COLLECTOR	May 05, 1981	Substantially Equivalent	WENMAR INTL. CORP.
K802739	URINE COLLECTION BAG TYPE 710AP	Dec 18, 1980	Substantially Equivalent	BIO D CORP.
K802738	URINE COLLECTION BAG TYPE 1505V	Dec 18, 1980	Substantially Equivalent	BIO D CORP.
K802737	URINE COLLECTION BAG TYPE 1590V	Dec 18, 1980	Substantially Equivalent	BIO D CORP.
K802736	URINE COOLECTION BAG TYPE 2090V	Dec 18, 1980	Substantially Equivalent	BIO D CORP.
K802735	URINE COLLECTION BAG TYPE 740AP	Dec 18, 1980	Substantially Equivalent	BIO D CORP.
K802734	URINE COLLECTION BAG TYPE 710	Dec 18, 1980	Substantially Equivalent	BIO D CORP.
K802733	URINE COLLECTION BAG TYPE AP2090V	Dec 18, 1980	Substantially Equivalent	BIO D CORP.
K802732	URINE COLLECTION BAG TYPE AP2132V	Dec 18, 1980	Substantially Equivalent	BIO D CORP.
K802729	URINE COLLECTION BAG TYPE 2132V	Dec 18, 1980	Substantially Equivalent	BIO D CORP.
K802667	ARGYLE CLOSED URINARY DRAINAGE SET	Dec 16, 1980	Substantially Equivalent	SHERWOOD MEDICAL CO.
K802664	URINARY DRAINAGE UNT	Nov 12, 1980	Substantially Equivalent	DIAMED DIVISION ILL. TOOL WORKS, INC.
K802606	LEG BAG EXTENSION TUBE	Oct 31, 1980	Substantially Equivalent	ASSOCIATED MEDICAL PRODUCTS CO.
K802433	BARD MALE EXTERNAL CATHETER	Oct 31, 1980	Substantially Equivalent	C.R. BARD, INC.
K802173	URIHESIVE STRIPS	Sep 26, 1980	Substantially Equivalent	E. R. SQUIBB & SONS, INC.
K802172	URIHESIVE SYSTEM	Sep 26, 1980	Substantially Equivalent	E. R. SQUIBB & SONS, INC.
K802012	TRIBAG, URINE BAG SYSTEM #1109,& 1301-12	Sep 09, 1980	Substantially Equivalent	POLLAK (INTL.), LTD.
K801711	BK-6010 CATHETER TUBE HOLDER	Aug 13, 1980	Substantially Equivalent	FRED SAMMONS, INC.
K801629	COVER-ALL MALE INCONTINENCE DEVICE	Aug 12, 1980	Substantially Equivalent	THE UROLOGY GROUP
K801522	ARGYLE RIGID URINE MEASURING/COLL. DEV.	Jul 28, 1980	Substantially Equivalent	SHERWOOD MEDICAL CO.
K801021	URINEBAG	Jul 28, 1980	Substantially Equivalent	UNOVEX OF DENMARK
K800890	LINEBERGER EXTERNAL MALE CATHETER	Jun 20, 1980	Substantially Equivalent	LINEBERGER EXTERNAL CATHETER CO.
K800694	MMG DISPOSABLE URINARY LEG BAG	May 30, 1980	Substantially Equivalent	MEDICAL MARKETING GROUP
K800186	LOGO-NU-WAY	Feb 26, 1980	Substantially Equivalent	GARY GIANCARLO
K791969	DYNACOR STERILE CLOSED SYS. DRAINAGE BAG	Nov 05, 1979	Substantially Equivalent	MEDLINE INDUSTRIES, INC.
K791265	CONPHAR URINARY DRAINAGE BAG-2000ML	Sep 07, 1979	Substantially Equivalent	CONPHAR, INC.
K791252	CONPHAR FEMALE CATHETER W/BAG-STERILE	Sep 07, 1979	Substantially Equivalent	CONPHAR, INC.
K791270	CONPHAR LEG BAG	Aug 03, 1979	Substantially Equivalent	CONPHAR, INC.
K791262	CONPHAR URINARY DRAINAGE BAG 2000ML	Aug 03, 1979	Substantially Equivalent	CONPHAR, INC.
K791251	CONPHAR LEG BAG-STERILE	Aug 03, 1979	Substantially Equivalent	CONPHAR, INC.
K791245	CONPHAR EXTERNAL CATHETER	Aug 03, 1979	Substantially Equivalent	CONPHAR, INC.
K791198	BIBAG	Jul 30, 1979	Substantially Equivalent	AB MEDETT PRODUKTER
K791196	URIDROP	Jul 30, 1979	Substantially Equivalent	AB MEDETT PRODUKTER
K790969	ARGYLE URINE METER	Jun 27, 1979	Substantially Equivalent	SHERWOOD MEDICAL CO.
K790253	URINARY DRAINAGE BAG	Apr 10, 1979	Substantially Equivalent	SNYDER LABORATORIES, INC.
K790279	CATHETER, MMG LATEX EXTERNAL	Mar 06, 1979	Substantially Equivalent	MEDICAL MARKETING GROUP
K790174	BK-6021 CONDOM CATHETER HOLDER	Feb 08, 1979	Substantially Equivalent	FRED SAMMONS, INC.
K781780	CATHETER, EXTERNAL MALE NURSING CARE	Dec 07, 1978	Substantially Equivalent	MEDI-TECH, INC.
K781521	CUTTER RESIFLEX URINE METER	Nov 22, 1978	Substantially Equivalent	CUTTER LABORATORIES, INC.
K781433	AKRON MALE EXTERNAL CATHETER	Nov 03, 1978	Substantially Equivalent	LATEX IND., INC.
K781422	KWIK-FLO URINAL SYSTEM	Sep 07, 1978	Substantially Equivalent	THE GRACE MFG. CO.
K780878	LEG BAG	Jul 31, 1978	Substantially Equivalent	ABCO DEALERS, INC.
K780837	URINARY DRAINAGE BAG	Jul 27, 1978	Substantially Equivalent	INTERMED, INC.
K780831	URINARY CATHETERIZATION SYSTEM W/O FOLEY	Jul 27, 1978	Substantially Equivalent	MEDICAL DEVICES, INC.
K770789	URI-DRAIN COMBO KIT FOR MALE INCONTINENC	Oct 18, 1977	Substantially Equivalent	CHESEBROUGH-POND'S U.S.A. CO.
K771435	URINARY LEG BAG, STEOILE	Sep 20, 1977	Substantially Equivalent	MEDDEV INTERNATIONAL CORP.
K770762	BAG, URINARY, DRAINAGE, 2D9013	May 10, 1977	Substantially Equivalent	TRAVENOL LABORATORIES, S.A.
K770673	COLLECTOR, SANI-CATCH, NO. 1014	Apr 15, 1977	Substantially Equivalent	CONCORD LABORATORIES, INC.
K770672	COLLECTOR, SANI-CATCH, NO. 1010	Apr 15, 1977	Substantially Equivalent	CONCORD LABORATORIES, INC.
K770516	MEMBRANE SOURCE-EX SERIES DIALYZER CART.	Mar 30, 1977	Substantially Equivalent	EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K770557	DRAINAGE BAG, 4000 ML.	Mar 24, 1977	Substantially Equivalent	CONCORD LABORATORIES, INC.
K770497	DRAINAGE UNIT, COMBINATION	Mar 21, 1977	Substantially Equivalent	CONCORD LABORATORIES, INC.
K770490	DRAINAGE BAG, IMPROVED, FLAT	Mar 21, 1977	Substantially Equivalent	PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K770320	URINARY DRAINAGE SET, CLOSED, STERILE	Mar 16, 1977	Substantially Equivalent	MEDICAL DEVICES, INC.
K770399	VALVE FOR CLOSED SYS. URINARY DRAINAGE	Mar 09, 1977	Substantially Equivalent	WILL ROSS CO.
K761360	8 LATEX EXTENSION TUBE WITH CONNECTOR	Jan 10, 1977	Substantially Equivalent	INTERMED, INC.
K761039	URINARY LEG BAG DRAINAGE TUBE	Dec 02, 1976	Substantially Equivalent	PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K760260	BAG, DISPOSABLE URINARY LEG	Oct 20, 1976	Substantially Equivalent	INTERMED, INC.
K760069	BAG, LEG, URINE COLLECTING DEVICE	Oct 20, 1976	Substantially Equivalent	PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K760105	BAG, URINE COLLECTION, CLOSED SYSTEM	Oct 07, 1976	Substantially Equivalent	CONCORD LABORATORIES, INC.

FEI Numbers

This FDA classification entry is associated with 125 FEI numbers. Click on an entry to view related FDA registrations.

1000112877: 433 registrations

1000112968: 424 registrations

1000160458: 173 registrations

1000237915: 108 registrations

1000306431: 841 registrations

1018233: 409 registrations

1043214: 577 registrations

1043646: 37 registrations

1314417: 210 registrations

1417592: 699 registrations

1420054: 89 registrations

1643817: 565 registrations

1921846: 275 registrations

2022388: 32 registrations

2023344: 12 registrations

2024311: 106 registrations

2433012: 92 registrations

2648727: 162 registrations

3001044237: 23 registrations

3001236905: 677 registrations

3002504068: 11 registrations

3002771993: 1 registration

3002806591: 22 registrations

3002806934: 112 registrations

3002807111: 309 registrations

3002807634: 14 registrations

3002902735: 417 registrations

3002907620: 375 registrations

3002963732: 68 registrations

3003040625: 290 registrations

3003063934: 24 registrations

3003076831: 367 registrations

3003154916: 41 registrations

3003627840: 15 registrations

3003717263: 5 registrations

3003755374: 9 registrations

3004365956: 231 registrations

3004458261: 18 registrations

3005011024: 409 registrations

3005273623: 226 registrations

3005596530: 50 registrations

3005636544: 59 registrations

3005669815: 67 registrations

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3005987240: 63 registrations

3006082230: 372 registrations

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3006279007: 29 registrations

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3006542380: 44 registrations

3006993165: 33 registrations

3007007790: 84 registrations

3007289408: 107 registrations

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3009337401: 60 registrations

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3010291427: 90 registrations

3010305275: 31 registrations

3010339057: 41 registrations

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3010806410: 9 registrations

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3011020307: 6 registrations

3011707784: 40 registrations

3011814545: 9 registrations

3011987967: 104 registrations

3012050423: 50 registrations

3012251300: 20 registrations

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3012568936: 22 registrations

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3013429557: 12 registrations

3013522936: 3 registrations

3013552412: 13 registrations

3013557562: 654 registrations

3014198390: 11 registrations

3014200871: 6 registrations

3014208300: 17 registrations

3014421917: 283 registrations

3014498861: 9 registrations

3014615028: 18 registrations

3014637079: 29 registrations

3014656749: 53 registrations

3015009174: 8 registrations

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3015176887: 12 registrations

3015268290: 26 registrations

3015479927: 8 registrations

3015821396: 34 registrations

3016159368: 18 registrations

3016171914: 22 registrations

3016616327: 7 registrations

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3016702790: 7 registrations

3016763307: 51 registrations

3016884033: 14 registrations

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3018116884: 33 registrations

3018503755: 34 registrations

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3022866893: 1 registration

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3034669683: 127 registrations

3034670959: 14 registrations

3038624153: 6 registrations

3932: 18 registrations