Medical Device Manufacturer · US , Spencer , IN

Cook Urological, Inc. - FDA 510(k) Cleared Devices

104 submissions · 102 cleared · Since 1986

104

Total

102

Cleared

0

Denied

56 devices

26-50 of 56

Cleared Dec 07, 1993

URETERAL CATHETER

Gastroenterology & Urology · 498d

Cleared Nov 17, 1993

DILATING URETHRAL SOUND

Gastroenterology & Urology · 97d

Cleared Oct 08, 1993

SILICONE RECTAL BALLOON

Gastroenterology & Urology · 269d

Cleared Jul 09, 1993

ONIK-COHEN ACCESS SET

Gastroenterology & Urology · 154d

Cleared Jul 02, 1993

VASOVASOSTOMY SET

Gastroenterology & Urology · 457d

Cleared Jun 07, 1993

Gastroenterology & Urology · 349d

Cleared Mar 05, 1993

ILLUMINATED URETERAL CATHETER

Gastroenterology & Urology · 235d

Cleared Nov 10, 1992

MALECOT-NEPHROSTOMY TAMPONADE CATHETER

Gastroenterology & Urology · 358d

Cleared Aug 07, 1992

Gastroenterology & Urology · 88d

Cleared Aug 04, 1992

FLEXIBLE CYSTOSCOPY INTRODUCING CATHETER

Gastroenterology & Urology · 148d

Cleared Jul 02, 1992

URINARY DIVERSION EVACUATING CATHETER

Gastroenterology & Urology · 258d

Cleared Mar 18, 1992

ACCENT DG BALLOON URTERAL DILATOR SET, 10CM

Gastroenterology & Urology · 110d

Cleared Feb 19, 1992

URODYNAMIC CATHETER

Gastroenterology & Urology · 76d

Cleared Jan 30, 1992

NAUDE URETHRAL STENT

Gastroenterology & Urology · 216d

Cleared Jan 09, 1992

ECHOSIGHT STENT SET

Gastroenterology & Urology · 107d

Cleared Dec 02, 1991

URODYNAMIC RECTAL BALLOON

Gastroenterology & Urology · 182d

Cleared May 28, 1991

AUTOCATH(TM) SET

Gastroenterology & Urology · 88d

Cleared Apr 12, 1991

ACCENT DG BALLOON URETERAL DILATOR SET

Gastroenterology & Urology · 133d

Cleared Feb 16, 1990

WILLIAMS PENILE ANESTHETIC RETAINER

Gastroenterology & Urology · 115d

Cleared Nov 17, 1989

URETHRAL BALLOON DILATION CATHETER SET

Gastroenterology & Urology · 213d

Cleared Apr 07, 1989

BALLOON (NEPHROSTOMY TRACT) DILATION CATHETER SET

Gastroenterology & Urology · 24d

Cleared Aug 04, 1988

BALL TIP FULGURATING ELECTRODE, 3 FRENCH

Gastroenterology & Urology · 162d

Cleared Aug 02, 1988

VPI NON-ADHESIVE CONDOM CATHETER

Gastroenterology & Urology · 8d

Cleared Apr 11, 1988

3 FRENCH FLEXIBLE BIOPSY FORCEPS

Gastroenterology & Urology · 7d

Cleared Mar 15, 1988

COOK UROLOGICAL WIRE GUIDE W/HYDROMER COATING

Gastroenterology & Urology · 63d