KOB · Class II · 21 CFR 876.5090

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

Leading manufacturers include Cook Incorporated, Cook Urological, Inc. and Van-Tec, Inc..

32
Total
32
Cleared
98d
Avg days
1978
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 253d recently vs 93d historically

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 Apr 23, 1997
KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET
K970969
The Kendal Co.
Gastroenterology & Urology · 37d
Cleared Aug 18, 1995
LINDNER/GOLOMB SP INTRODUCING SOUND
K953024
Cook Urological, Inc.
Gastroenterology & Urology · 50d
Cleared Nov 22, 1991
SUPRAPUBIC FLOW CONTROLLER
K904798
Olympus Corp.
Gastroenterology & Urology · 394d
Cleared May 04, 1990
MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER
K901603
Bivona Medical Technologies
Gastroenterology & Urology · 38d
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
Cleared Aug 08, 1985
PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET
K852287
Cook Ob/Gyn
Gastroenterology & Urology · 71d
Cleared Oct 04, 1984
SEXTON CYSTOTOMY URINE PUMP
K843158
Holter-Hausner Intl.
Gastroenterology & Urology · 55d
Cleared Dec 31, 1981
CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET
K813084
Burron Medical Products, Inc.
Gastroenterology & Urology · 59d
Cleared Apr 08, 1980
SUPRAPUBIC TROCAR
K800607
G.D. Searle and Co.
Gastroenterology & Urology · 22d

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 increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - KOB Product Code

Recent submissions under KOB have taken an average of 253 days to reach a decision - up from 93 days historically. Manufacturers should account for longer review timelines in current project planning.

KOB devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →