Cook Ultra Quiet Vacuum Pump & Regulator

• 2 recalls, same reason

  • Terminated Z-1460-2018 FDA Class II ·initiated 22 Mar 2018
  • Terminated Z-1461-2018 FDA Class II ·initiated 22 Mar 2018

  Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or electric shock or burn to the user.

510(k) Number

K992070 ↗

FDA Product Code

MQG

Device Class

Class II

Regulation

21 CFR Part 884.6120

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

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See all devices from Cook Urological, Inc. →