KOE · Class II · 21 CFR 876.5520

FDA Product Code KOE: Dilator, Urethral

Leading manufacturers include American Medical Systems, Inc., Vance Products, Inc. and Van-Tec, Inc..

27
Total
27
Cleared
124d
Avg days
1979
Since

FDA 510(k) Cleared Dilator, Urethral Devices (Product Code KOE)

27 devices
1–24 of 27
Cleared Jan 02, 2020
Optilume Basic Urological Balloon Dilation Catheter
K191061
Urotronic, Inc.
Gastroenterology & Urology · 255d
Cleared Oct 10, 1997
ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE
K972964
Atrion Medical Products, Inc.
Gastroenterology & Urology · 60d
Cleared Oct 21, 1996
BARD EAGLE INFLATION DEVICE
K962611
Ryder Intl. Corp.
Gastroenterology & Urology · 110d
Cleared Oct 18, 1996
AQ HYDROPHILIC DILATORS
K961904
Cook Urological, Inc.
Gastroenterology & Urology · 155d
Cleared Oct 28, 1992
120 FR OPTILUME PROSTATE BALLOON DILATOR
K920551
American Medical Systems, Inc.
Gastroenterology & Urology · 265d
Cleared Aug 14, 1992
DOWD(TM) II
K922349
Boston Scientific Corp
Gastroenterology & Urology · 87d
Cleared May 06, 1992
ENTRAC URETHRAL BALLOON DILATATION CATHETER
K920711
American Medical Systems, Inc.
Gastroenterology & Urology · 78d
Cleared Dec 27, 1991
APEX(TM) PROSTATIC BALLOON DILATION CATHETER
K913477
Peripheral Systems Group
Gastroenterology & Urology · 144d
Cleared May 17, 1990
AMS OPTILUME INFLATION SYRINGE
K900760
American Medical Systems, Inc.
Gastroenterology & Urology · 90d
Cleared May 17, 1990
AMS OPTILUME(TM) PROSTATE BALLOON DILATOR
K900761
American Medical Systems, Inc.
Gastroenterology & Urology · 90d
Cleared Nov 17, 1989
URETHRAL BALLOON DILATION CATHETER SET
K892855
Cook Urological, Inc.
Gastroenterology & Urology · 213d
Cleared Jul 31, 1989
PROSTATIC URETHRO. BALLOON DILATATION CATHETER
K873295
Medi-Tech, Inc.
Gastroenterology & Urology · 714d
Cleared Mar 10, 1987
VAN-TEC URETHRAL DILATATION SYSTEM
K870695
Van-Tec, Inc.
Gastroenterology & Urology · 19d
Cleared Apr 15, 1985
VAN-TEC MEATAL DILATOR
K851158
Van-Tec, Inc.
Gastroenterology & Urology · 24d
Cleared May 09, 1984
KOLLMANN URETHRAL DILATOR
K841386
Imm Enterprises , Ltd.
Gastroenterology & Urology · 43d
Cleared Apr 13, 1984
URETERAL DILATOR
K840746
American Edwards Laboratories
Gastroenterology & Urology · 85d
Cleared Jul 10, 1981
VNACE FASCIAL DILATOR SET
K811833
Vance Products, Inc.
Gastroenterology & Urology · 10d
Cleared Mar 20, 1981
VANCE URETHAL DILATOR SET
K810371
Vance Products, Inc.
Gastroenterology & Urology · 36d
Cleared Apr 08, 1980
URETHRAL SOUND
K800610
G.D. Searle and Co.
Gastroenterology & Urology · 22d
Cleared Apr 08, 1980
BOUGIE A BOULE
K800611
G.D. Searle and Co.
Gastroenterology & Urology · 22d
Cleared Dec 06, 1979
VANCE MALLEABLE TIP FILIFORM
K792219
Vance Products, Inc.
Gastroenterology & Urology · 31d
Cleared Dec 06, 1979
VANCE PHILIPS FOLLOWER CATHETER & BOUGIE
K792221
Vance Products, Inc.
Gastroenterology & Urology · 31d

About Product Code KOE - Regulatory Context