Product Code: KOB FDA class 2 21 CFR 876.5090

Catheter, Suprapubic (And Accessories)

Gastroenterology, Urology

A Suprapubic Catheter with Accessories is a urological device inserted through the anterior abdominal wall into the bladder to provide urinary drainage in patients who cannot undergo or tolerate urethral catheterization, such as those with urethral obstruction, injury, or certain neurological conditions. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket notification. The product code is KOB and the applicable regulation is 21 CFR 876.5090 in the Gastroenterology and Urology specialty. This device is an implant.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: KOB
Device Class: FDA class 2
Regulation Number: 876.5090
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 32 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K240514	AMT Low-Profile Suprapubic Catheter & Drainage Set	Nov 01, 2024	Substantially Equivalent	Applied Medical Technology, Inc.
K181097	Cook Cystostomy Catheter Set	Jan 18, 2019	Unknown	Cook Incorporated
K182709	One-Step Suprapubic Introducer	Dec 26, 2018	Substantially Equivalent	Cook Incorporated
K182066	O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set	Oct 30, 2018	Unknown	Cook Incorporated
K132890	SUPRAPUBIC CATHETER AND INTRODUCER SET	Jan 17, 2014	Substantially Equivalent	Mediplus , Ltd.
K120127	SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM	Oct 26, 2012	Substantially Equivalent	Swan Valley Medical, Incorporated
K014002	ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890	Mar 04, 2002	Substantially Equivalent	Fortune Medical Instrument Corp.
K012153	LOWSLEY SUPRAPUBIC TRACTOR	Sep 19, 2001	Substantially Equivalent	Circon Video
K970969	KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET	Apr 23, 1997	Substantially Equivalent	The Kendal Co.
K970021	RUSCH SUPRAPUBIC TRAY	Feb 07, 1997	Substantially Equivalent	Rusch, Inc.
K945480	MOSS(R) STEEL BREAKAWAY(R) INTRODUCER	Aug 28, 1995	Substantially Equivalent	Harry A. Schlakman
K953024	LINDNER/GOLOMB SP INTRODUCING SOUND	Aug 18, 1995	Substantially Equivalent	Cook Urological, Inc.
K952187	RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILE	Jul 25, 1995	Substantially Equivalent	Rusch, Inc.
K921071	DENTOLOCK	Mar 26, 1992	Substantially Equivalent	Dentmed , Ltd.
K904798	SUPRAPUBIC FLOW CONTROLLER	Nov 22, 1991	Substantially Equivalent	Olympus Corp.
K904434	SEXTON CYSTOTOMY URINE PUMP (SCUP2)	Feb 01, 1991	Substantially Equivalent	Phoenix Bioengineering, Inc.
K901938	SUPER STRENGTH DENTURE ADHESIVE CREAM	Jun 06, 1990	Substantially Equivalent	Teledyne Getz
K901603	MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER	May 04, 1990	Substantially Equivalent	Bivona Medical Technologies
K884061	ADD-A-CATH	Oct 25, 1988	Substantially Equivalent	Femcare , Ltd.
K881097	SPEC 5* SUPRAPUBIC CATHETER	Jun 03, 1988	Substantially Equivalent	Porges Corp.
K874530	URETHRAL DILATOR ENDOSCOPE	Jan 27, 1988	Substantially Equivalent	Advanced Surgical Intervention, Inc.
K870556	VAN-TEC C-FLEX SUPRAPUBIC BALLOON CATHETER SET	Mar 10, 1987	Substantially Equivalent	Van-Tec, Inc.
K870555	VAN-TEC PEDIATRIC SUPRAPUBIC CATHETER SET	Mar 10, 1987	Substantially Equivalent	Van-Tec, Inc.
K863386	VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS	Oct 24, 1986	Substantially Equivalent	Angiomed U.S., Inc.
K863120	(STAMEY) T.U.R.P. SUPRAPUBIC CATHETER SET	Oct 24, 1986	Substantially Equivalent	Cook Urological, Inc.
K852287	PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET	Aug 08, 1985	Substantially Equivalent	Cook Ob/Gyn
K852200	SIMPLASTIC SUPRA PUBIC CATHETER	Aug 07, 1985	Substantially Equivalent	Franklin Medical USA, Inc.
K843158	SEXTON CYSTOTOMY URINE PUMP	Oct 04, 1984	Substantially Equivalent	Holter-Hausner Intl.
K813084	CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET	Dec 31, 1981	Substantially Equivalent	Burron Medical Products, Inc.
K810368	VANCE PERCUTANEOUS MALECOT NEPHROSTOMY	Mar 20, 1981	Substantially Equivalent	Vance Products, Inc.
K800607	SUPRAPUBIC TROCAR	Apr 08, 1980	Substantially Equivalent	G.D. Searle and Co.
K780765	PERCUTANEOUS SURAPUBIC CATHETER	Jul 17, 1978	Substantially Equivalent	Vance Products, Inc.