Sydney Ivf Culture Oil

• • Terminated Z-1324-2012 FDA Not yet classified ·initiated 15 Feb 2012

  Cook Medical is recalling Sydney IVF Culture Oil due to a number of recent customer complaints that have identified it as a possible cause of embryo degeneration at day 5/6.

510(k) Number

K022002 ↗

FDA Product Code

MQL

Device Class

Class II

Regulation

21 CFR Part 884.6180

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

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See all devices from Cook Urological, Inc. →