Medical Device Manufacturer · US , Bloomington , IN

Cook Ob/Gyn - FDA 510(k) Cleared Devices

43 submissions · 43 cleared · Since 1985

Recent clearances: BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500, SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT, SYDNEY IVF EMBRYO BIOPSY MEDIUM

43

Total

43

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cook Ob/Gyn General & Plastic Surgery ✕

5 devices

1-5 of 5

Cleared Sep 06, 1994

DISPOSABLE LAPAROSCOPIC SWAB WITH REUSABLE HANDLE

General & Plastic Surgery · 22d

Cleared Jul 22, 1993

COOK ASPIRATION UNIT

General & Plastic Surgery · 150d

Cleared Apr 02, 1992

General & Plastic Surgery · 252d

Cleared Aug 23, 1989

DIRECTABLE COAXIAL CATHETER SET

General & Plastic Surgery · 29d

Cleared Nov 14, 1988

General & Plastic Surgery · 14d