Medical Device Manufacturer · US , Mchenry , IL

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

190 submissions · 179 cleared · Since 1976

190

Total

179

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cook, Inc. Obstetrics & Gynecology ✕

5 devices

1-5 of 5

Cleared Sep 27, 2013

COOK CERVICAL RIPENING BALLOON

Obstetrics & Gynecology · 151d

Cleared Oct 12, 1990

LAPAROSCOPIC ACCESS SHEATH SET

Obstetrics & Gynecology · 88d

Cleared Oct 12, 1990

HYSTEROSCOPY SHEATH SET

Obstetrics & Gynecology · 86d

Cleared Sep 26, 1990

DEFLECTING WIRE GRASPER

Obstetrics & Gynecology · 42d

Cleared Dec 08, 1988

COOK HYSTEROCATH(TM)

Obstetrics & Gynecology · 57d