FDA Product Code KOE: Dilator, Urethral

Cleared Jan 02, 2020

Optilume Basic Urological Balloon Dilation Catheter

K191061

Urotronic, Inc.

Gastroenterology & Urology · 255d

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 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 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