Licox® IM2

• • 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.

Trade Name

Licox®

Generic Name

Neurosurgical procedure kit, non-medicated, single-use

Model / Ref / Catalog

IM2

Primary DI / UDI-DI

10381780041108

510(k) Number

K002765 ↗

FDA Product Code

GWM

GMDN Term

Neurosurgical procedure kit, non-medicated, single-use

Device Class

Class II

Regulation Number

882.1620

GUDID distribution status

Not in Commercial Distribution