Product Code: KNY FDA class 2 21 CFR 876.5130

Accessories, Catheter, G-U

Gastroenterology, Urology

Genitourinary Catheter Accessories are supplementary devices used in conjunction with urological catheters, including connectors, caps, drainage bags, and stabilization components that support catheter management and urinary drainage in clinical and home care settings. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket notification. The product code is KNY and it is regulated under 21 CFR 876.5130 in the Gastroenterology and 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: KNY
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 64 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K182144	Bi-Flex Evo	Sep 07, 2018	Substantially Equivalent	Promepla Sam
K162356	Vesair Cystoscopic Sheath	Mar 02, 2017	Substantially Equivalent	Solace Therapeutics
K140441	BI-FLEX URETERAL ACCESS SHEATH	Jun 17, 2014	Substantially Equivalent	Promepla Sam
K140562	WIJAY EZ-VOID EXTERNAL CATHETER VALVE	Jun 16, 2014	Substantially Equivalent	Leomed, LLC
K141252	GUARDIAN URETHRAL SHEATH	Jun 09, 2014	Substantially Equivalent	Solace Therapeutics
K131803	GUARDIAN URETHRAL SHEATH	Aug 20, 2013	Substantially Equivalent	Solace Therapeutics
K123170	VARI-PASS VARIABLE LENGTH ACCESS SHEATH	Feb 04, 2013	Substantially Equivalent	Olympus Surgical Technologies America
K120160	ROCAMED ROCAUS PLATINUM	May 14, 2012	Substantially Equivalent	Promepla Sam
K112209	PREFILLED CATHETER INFLATION SYRINGE	Sep 08, 2011	Substantially Equivalent	Avail Medical Products, Inc.
K090121	PRE-FILLED CATHETER INFLATION SYRINGE	Apr 15, 2009	Substantially Equivalent	Avail Medical Products, Inc.
K052298	CYSTOGLIDE INTRODUCER SHEATH	Dec 12, 2006	Substantially Equivalent	Percutaneous Systems, Incorporated
K062240	CAREVENT	Oct 16, 2006	Substantially Equivalent	Chief Medical, LLC
K052952	CATHASSIST	May 14, 2006	Substantially Equivalent	Physician Technologies, Inc.
K052134	CYSTOGLIDE DILATING INTRODUCER SHEATH	Sep 22, 2005	Substantially Equivalent	Percutaneous Systems, Inc.
K051593	UROPASS URETERAL ACCESS SHEATH, MODEL 61224	Sep 02, 2005	Substantially Equivalent	Acmi Corporation
K042531	UPDATED SLIP UROLOGY INTRODUCER SHEATH	Feb 01, 2005	Substantially Equivalent	Percutaneous Systems, Incorporated
K042877	MICROVERTER URETERAL ACCESS SHEATH	Nov 16, 2004	Substantially Equivalent	Percutaneous Systems, Inc.
K040520	SLIP UROLOGY INTRODUCER SHEATH	May 20, 2004	Substantially Equivalent	Percutaneous Systems, Inc.
K032127	HEMEDEX FIXATION DEVICE	Dec 30, 2003	Substantially Equivalent	Hemedex Incorporated
K023690	CATHETER CONNECTOR	Feb 28, 2003	Substantially Equivalent	World Metals, Inc.
K000767	MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201	Jun 05, 2000	Substantially Equivalent	Memcath Technologies, LLC
K991097	PBN DRAINAGE CATHETER GUIDEWIRES	Apr 23, 1999	Substantially Equivalent	Medical Device Technologies, Inc.
K981611	SNAP-N-PEEL INTRODUCERS	Jul 30, 1998	Substantially Equivalent	Circon Corp.
K981667	HYDROPHILIC COATED GUIDEWIRE	Jun 05, 1998	Substantially Equivalent	Lake Region Mfg., Inc.
K981229	MANAN MANTA CATHETER FIXATION DISK	Apr 22, 1998	Substantially Equivalent	Medical Device Technologies, Inc.
K972977	INSULATOR WIRE GUIDE	Oct 10, 1997	Substantially Equivalent	Cook Urological, Inc.
K960866	LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS.	Apr 05, 1996	Substantially Equivalent	Lake Region Mfg., Inc.
K954132	MANAN MANTA CATHETER FIXATION DISK	Mar 26, 1996	Substantially Equivalent	Manan Medical Products, Inc.
K952414	PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER	Jun 23, 1995	Substantially Equivalent	Acacia Laboratories, Inc.
K951995	KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR	May 24, 1995	Substantially Equivalent	Karl Storz Endoskop GmbH
K951488	KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP	Apr 25, 1995	Substantially Equivalent	The Kendal Co.
K943835	PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID	Jan 24, 1995	Substantially Equivalent	Orion Life Systems, Inc.
K944754	AMPLATZ SUPER STIFF GUIDEWIRE	Oct 07, 1994	Substantially Equivalent	Boston Scientific Corp
K944135	UROLOGICAL GUIDWIRE	Sep 21, 1994	Substantially Equivalent	Applied Medical Resources
K934072	CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM	Sep 08, 1994	Unknown	Contour Fabricators of Florida, Inc.
K942205	ZEBRA UROLOGICAL GUIDEWIRE	Jul 07, 1994	Substantially Equivalent	Boston Scientific Corp
K942074	FLEXFINDER GUIDEWIRE	Jun 24, 1994	Substantially Equivalent	Flexmedics
K935643	SYRIGENE ACETIC ACID PRE-FILLEDSYRINGE	Jun 10, 1994	Substantially Equivalent	Regulatory & Marketing Services, Inc.
K932143	FLEXI-TRAK ANCHORING DEVICE	Dec 01, 1993	Substantially Equivalent	Convatec, A Division of E.R. Squibb & Sons
K931013	FOLEY CATHETER TRAY	Aug 09, 1993	Substantially Equivalent	Kit Pak, Inc.
K926039	GUIDE-TECH ENCAPSULATED GUIDEWIRE	Aug 05, 1993	Substantially Equivalent	Cape Tech Medical Products
K925161	NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO	Jul 21, 1993	Substantially Equivalent	North American Sterilization & Packaging Co.
K923496	URINARY CARE SUPPLIES	May 27, 1993	Unknown	Orion Life Systems, Inc.
K925281	KIT PAK URINARY CARE SUPPLIES	Apr 19, 1993	Unknown	Kit Pak, Inc.
K926344	HYDROPHILIC COATED GUIDEWIRE	Mar 05, 1993	Substantially Equivalent	Surgitek
K921200	GUIDEWIRE	Sep 04, 1992	Substantially Equivalent	Lake Region Mfg., Inc.
K921055	KENDALL CURITY KIDS PEDIATRIC DRAINAGE ADAPTER	May 11, 1992	Substantially Equivalent	Kendall Healthcare Products Co. Div.Of Tyco Health
K912919	MENTOR INFUSION LINE	Dec 13, 1991	Substantially Equivalent	Mentor Corp.
K914211	CATH CONTROL	Nov 22, 1991	Substantially Equivalent	Highpoint Medical Corp.
K913679	UNIVERSAL SWIVEL PATCH	Sep 05, 1991	Substantially Equivalent	Bryman Medical
K912146	URETERAL CATHETER HOLDER	Jul 26, 1991	Substantially Equivalent	Inman Liebelt Corp.
K905128	FLEXI-TRAK(TM) ANCHORING DEVICE	Nov 29, 1990	Substantially Equivalent	Convatec, A Division of E.R. Squibb & Sons
K900031	MODIFIED PEDIATRIC SILICONE FOLEY CATHETERS	Mar 06, 1990	Substantially Equivalent	Porges Corp.
K896806	CATHETER PLUG/PROTECTOR	Feb 26, 1990	Substantially Equivalent	Westmark, Sterile Packing Systems, Inc. (Sps)
K890072	PRIMROSE FEMALE EXT. CATH OR EXT. URINARY DRAINAGE	Jun 12, 1989	Substantially Equivalent	Medireach, Inc.
K884819	O'NEIL URINARY CATHETER INTRODUCER	Feb 17, 1989	Substantially Equivalent	Medical Marketing Group
K881878	CATHETER WITHDRAWAL UNIT	Jul 28, 1988	Substantially Equivalent	Eris Medical Technology
K882641	TECNOL CATHETER LEG STRAP	Jul 12, 1988	Substantially Equivalent	Tecnol New Jersey Wound Care, Inc.
K873288	CLOSED FOLEY CATHETER SYSTEM	Nov 27, 1987	Unknown	Todd Medical, Inc.
K833242	DEFLECTING GUIDE WIRE	Oct 19, 1983	Substantially Equivalent	Van-Tec, Inc.
K821336	TRANSENDOSCOPIC INJECTION CATHETER TEI	May 21, 1982	Substantially Equivalent	Sounson Research Co., Inc.
K781987	URINARY DRAINAGE BAG	Dec 04, 1978	Substantially Equivalent	Kelsar Corp.
K771212	SAFEED DISP. PLASTIC CATHETER	Sep 12, 1977	Substantially Equivalent	Terumo America, Inc.
K760943	SILASTIC BRAND GASTRIC LAVAGE TUBE	Nov 23, 1976	Substantially Equivalent	Dow Corning Corp. Healthcare Industries Materials