Medical Device Manufacturer · US , Port Arthur , TX

Colon Therapeutics - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1984

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Colon Therapeutics Gastroenterology & Urology ✕

8 devices

1-8 of 8

Cleared Sep 29, 1997

JIMMY JOHN III RECTAL NOZZLE

Gastroenterology & Urology · 35d

Cleared Sep 09, 1997

JIMMY JOHN III RECTAL NOZZEL, MODEL CIT

Gastroenterology & Urology · 70d

Cleared Jul 20, 1988

Gastroenterology & Urology · 90d

Cleared Oct 14, 1987

MODIFIED RECTAL NOZZLE

Gastroenterology & Urology · 16d

Cleared Mar 17, 1987

MODIFIED JIMMY JOHN III

Gastroenterology & Urology · 67d

Cleared Mar 17, 1987

JIMMY JOHN III, COLONIC IRRIGATION SYSTEM

Gastroenterology & Urology · 47d

Cleared May 15, 1986

JIMMY JOHN III, RECTAL NOZZLE (MODIFICATION)

Gastroenterology & Urology · 64d

Cleared Oct 24, 1984

Gastroenterology & Urology · 154d