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

104 devices

76-100 of 104

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 May 18, 1992

LAPAROCOPIC MYOMA SCREW

Obstetrics & Gynecology · 171d

Cleared May 18, 1992

HYSTEROSCOPIC MYOMA SCREW

Obstetrics & Gynecology · 168d

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 Jun 28, 1991

COOK TISSUE MORCELLATOR

General & Plastic Surgery · 114d

Cleared May 28, 1991

AUTOCATH(TM) SET

Gastroenterology & Urology · 88d

Cleared Apr 12, 1991

ACCENT DG BALLOON URETERAL DILATOR SET

Gastroenterology & Urology · 133d

Cleared Mar 28, 1991

SURGICAL TISSUE POUCH

General & Plastic Surgery · 23d

Cleared Dec 03, 1990

DISPOSABLE INFLATION GAUGE

Cardiovascular · 167d

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

Cleared Apr 01, 1987

(URETEROSCOPIC) STRICTURE SCAPEL OR KNIFE

Gastroenterology & Urology · 62d

Cleared Feb 03, 1987

COOK-VPI CONTINENCE CUFF

Gastroenterology & Urology · 166d

Cleared Nov 07, 1986

COOK-VPI INTERMITTENT CATHETER

Gastroenterology & Urology · 87d

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