Monitorr Icp External Drainage and Monitoring Systems

• 2 recalls, same reason

  • Terminated Z-1310-2019 FDA Class I ·initiated 8 Apr 2019
  • Terminated Z-1311-2019 FDA Class I ·initiated 8 Apr 2019

  The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.

510(k) Number

K062599 ↗

FDA Product Code

JXG

Device Class

Class II

Regulation

21 CFR Part 882.5550

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• DuraGen® Suturable

  Class III

  CE/MDD

• Mayfield®

  Class I

  CE/MDR

• Integra Flow Regulating Valve Systems Osv II Models and Integra Flow Regulating Valve Low Flow Models

  Class II

  FDA 510(k) K140722 Active Cleared 6 Jan 2015

• INTEGRA Wound Matrix (Macro-Channels)

  Unclassified

  FDA 510(k) K210128 Active Cleared 8 Oct 2021

• Mayfield Radiolucent Disposable Skull Pins

  Class II

  FDA 510(k) K071458 Active Cleared 13 Jun 2007

• Licox Pmo Brain Monitoring System

  Class II

  FDA 510(k) K040235 Active Cleared 20 Apr 2004

See all devices from Integra Lifesciences Corporation →