Medical Device Manufacturer · US , Mchenry , IL

Northgate Research, Inc. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1980

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Northgate Research, Inc. Gastroenterology & Urology ✕

8 devices

1-8 of 8

Cleared Nov 16, 1990

1.9 FRENCH LITHOTRIPTER ELECTRODE

Gastroenterology & Urology · 114d

Cleared Oct 18, 1989

2.5 FRENCH LITHOTRIPTOR ELECTRODE

Gastroenterology & Urology · 85d

Cleared Mar 22, 1989

UROLOGICAL LOOP RETRIEVERS

Gastroenterology & Urology · 14d

Cleared Mar 22, 1989

UROLOGICAL GRASPING FORCEPS

Gastroenterology & Urology · 14d

Cleared Mar 22, 1989

UROLOGICAL STONE BASKET

Gastroenterology & Urology · 14d

Cleared Feb 10, 1987

Gastroenterology & Urology · 57d

Cleared Aug 21, 1985

5F ELECTRODE(LITHOTRIPTOR)

Gastroenterology & Urology · 44d

Cleared Nov 10, 1980

MODEL SD-1 DISINTEGRATOR

Gastroenterology & Urology · 48d