Cook Mini-Incubator

• • Terminated Z-0809-2021 FDA Class II ·initiated 16 Dec 2020

  A small percentage of the Disposable Humidification Flasks may have a manufacturing defect that can cause the silicone stoppers to dislodge or gas to leak from the flasks, impeding gas flow to the incubation chambers of the Mini Incubator.

• 2 recalls, same reason

  • Terminated Z-1377-2018 FDA Class II ·initiated 12 Jan 2018
  • Terminated Z-1378-2018 FDA Class II ·initiated 12 Jan 2018

  The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for proper gamete/embryo incubation due to fatigue failure of the flat flex lid heater.

510(k) Number

K983642 ↗

FDA Product Code

MQG

Device Class

Class II

Regulation

21 CFR Part 884.6120

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Stamey Needle

  Class I

  FDA 510(k) K884553 Active Cleared 14 Nov 1988

• Tubal Lumen Support

  Class II

  FDA 510(k) K932114 Active Cleared 27 Sep 1994

• Sholkoff Balloon Hysterosalpingography Catheter

  Class II

  FDA 510(k) K891290 Active Cleared 23 May 1989

• Bakri Postpartum Balloon, Model J-Sos-100500

  Class II

  FDA 510(k) K062438 Active Cleared 27 Oct 2006

• Balloon Dilation Catheter

  Class II

  FDA 510(k) K896448 Active Cleared 7 Mar 1990

• Laparoscopic Catherter

  Class II

  FDA 510(k) K903187 Active Cleared 12 Oct 1990

See all devices from Cook Ob/Gyn →