KOB · Class II · 21 CFR 876.5090

FDA Product Code KOB: Catheter, Suprapubic (and Accessories)

Leading manufacturers include Cook Incorporated, Rusch, Inc. and Cook Urological, Inc..

32
Total
32
Cleared
98d
Avg days
1978
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Catheter, Suprapubic (and Accessories) Devices (Product Code KOB)

32 devices
1–24 of 32
Cleared Nov 01, 2024
AMT Low-Profile Suprapubic Catheter & Drainage Set
K240514
Applied Medical Technology, Inc.
Gastroenterology & Urology · 253d
Cleared Jan 18, 2019
Cook Cystostomy Catheter Set
K181097
Cook Incorporated
Gastroenterology & Urology · 267d
Cleared Dec 26, 2018
One-Step Suprapubic Introducer
K182709
Cook Incorporated
Gastroenterology & Urology · 90d
Cleared Oct 30, 2018
O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set
K182066
Cook Incorporated
Gastroenterology & Urology · 90d
Cleared Jan 17, 2014
SUPRAPUBIC CATHETER AND INTRODUCER SET
K132890
Mediplus , Ltd.
Gastroenterology & Urology · 123d
Cleared Oct 26, 2012
SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM
K120127
Swan Valley Medical, Incorporated
Gastroenterology & Urology · 283d
Cleared Mar 04, 2002
ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890
K014002
Fortune Medical Instrument Corp.
Gastroenterology & Urology · 90d
Cleared Sep 19, 2001
LOWSLEY SUPRAPUBIC TRACTOR
K012153
Circon Video
Gastroenterology & Urology · 70d
Cleared Apr 23, 1997
KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET
K970969
The Kendal Co.
Gastroenterology & Urology · 37d
Cleared Feb 07, 1997
RUSCH SUPRAPUBIC TRAY
K970021
Rusch, Inc.
Gastroenterology & Urology · 35d
Cleared Aug 28, 1995
MOSS(R) STEEL BREAKAWAY(R) INTRODUCER
K945480
Harry A. Schlakman
Gastroenterology & Urology · 293d
Cleared Aug 18, 1995
LINDNER/GOLOMB SP INTRODUCING SOUND
K953024
Cook Urological, Inc.
Gastroenterology & Urology · 50d
Cleared Jul 25, 1995
RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILE
K952187
Rusch, Inc.
Gastroenterology & Urology · 77d
Cleared Mar 26, 1992
DENTOLOCK
K921071
Dentmed , Ltd.
Gastroenterology & Urology · 20d
Cleared Nov 22, 1991
SUPRAPUBIC FLOW CONTROLLER
K904798
Olympus Corp.
Gastroenterology & Urology · 394d
Cleared Feb 01, 1991
SEXTON CYSTOTOMY URINE PUMP (SCUP2)
K904434
Phoenix Bioengineering, Inc.
Gastroenterology & Urology · 126d
Cleared Jun 06, 1990
SUPER STRENGTH DENTURE ADHESIVE CREAM
K901938
Teledyne Getz
Gastroenterology & Urology · 37d
Cleared May 04, 1990
MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER
K901603
Bivona Medical Technologies
Gastroenterology & Urology · 38d
Cleared Oct 25, 1988
ADD-A-CATH
K884061
Femcare , Ltd.
Gastroenterology & Urology · 29d
Cleared Jun 03, 1988
SPEC 5* SUPRAPUBIC CATHETER
K881097
Porges Corp.
Gastroenterology & Urology · 80d
Cleared Jan 27, 1988
URETHRAL DILATOR ENDOSCOPE
K874530
Advanced Surgical Intervention, Inc.
Gastroenterology & Urology · 85d
Cleared Mar 10, 1987
VAN-TEC PEDIATRIC SUPRAPUBIC CATHETER SET
K870555
Van-Tec, Inc.
Gastroenterology & Urology · 28d
Cleared Mar 10, 1987
VAN-TEC C-FLEX SUPRAPUBIC BALLOON CATHETER SET
K870556
Van-Tec, Inc.
Gastroenterology & Urology · 28d
Cleared Oct 24, 1986
(STAMEY) T.U.R.P. SUPRAPUBIC CATHETER SET
K863120
Cook Urological, Inc.
Gastroenterology & Urology · 71d

About Product Code KOB - Regulatory Context

510(k) Submission Activity

32 total 510(k) submissions under product code KOB since 1978, with 32 receiving FDA clearance (average review time: 98 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.