Licox Cmp Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1, CC1.SB Luicox Imc Introducer Kits-Im, IM2, IM3, II1 Licoximc Tempe

• • Terminated Z-0831-2015 FDA Class II ·initiated 7 Nov 2014

  Due to a complaint, it was determined that multiple lots of Licox catheters manufactured since October 29, 2013 contained a smart card which was programmed with an inaccurate lkN2 value.

• • Terminated Z-1518-2011 FDA Unclassified (pre-2012) ·initiated 17 Dec 2010

  Certain LICOX CMP Tissue Oxygen Monitors could allow for underestimation of temperature values.

• • Terminated Z-0622-05 FDA Unclassified (pre-2012) ·initiated 21 Jan 2005 ·on shared 510(k) K002765

  LICOX Model C8.B temperature probes manufactured by GMS mbH, an Integra company, may exhibit progen (endotoxin) levels above the FDA limit of 2.15 endotoxin units per device. Elevated endotoxin levels may result in an increased patient risk of fever.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K002765 ↗

FDA Product Code

GWM

Device Class

Class II

Regulation

21 CFR Part 882.1620

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Auragen Cortical Surface Electrodes

  Class II

  FDA 510(k) K082250 Active Cleared 10 Oct 2008

• Camino Single Parameter Monitor, Model Spm-1

  Class II

  FDA 510(k) K031086 Active Cleared 14 May 2003

• Camino Intracranial Pressure Monitoring Catheter with Licox Imc Bolt Fitting, Model 110-4l

  Class II

  FDA 510(k) K022553 Active Cleared 20 Aug 2002

• Selector Quantum Ultrasonic Aspirator System

  Unclassified

  FDA 510(k) K042277 Active Cleared 29 Sep 2004

• Selector Integra Ultrasonic Surgical Aspirator, Model Om 1530000M3

  Unclassified

  FDA 510(k) K021989 Active Cleared 13 Sep 2002

• Monitorr Icp External Csf Drainage and Monitoring System

  Class II

  FDA 510(k) K022554 Active Cleared 23 Aug 2002

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