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Licox® C8B

by Integra LifeSciences Switzerland Sàrl

Licox® C8B is a Class II device made by Integra LifeSciences Switzerland Sàrl, cleared under FDA 510(k) K002765 on 24 Nov 2000 and listed in FDA GUDID since 4 Aug 2016 (UDI-DI 10381780250159), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

510(k) K002765

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10381780250159 UDI-DI Date4 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK002765 Date24 Nov 2000DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K002765 decided 24 Nov 2000 Active
  • FDA GUDID UDI-DI 10381780250159 listed 4 Aug 2016 Listed

Recalls

3 recalls · FDA

    • 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.

Timeline

5 dated events

  1. Cleared FDA 510(k) K002765
  2. Recall initiated FDA recalls Z-0622-05
  3. Recall initiated FDA recalls Z-1518-2011
  4. Recall initiated FDA recalls Z-0831-2015
  5. Listed FDA GUDID 10381780250159

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Licox®
Generic name
Intracerebral sensor catheter, short-term
Model / Ref / Catalog
C8B
Primary DI / UDI-DI
10381780250159
510(k) Number
FDA product code
GWM
GMDN term
Intracerebral sensor catheter, short-term
Device class
Class II
Regulation number
882.1620
GUDID distribution status
In Commercial Distribution

Related devices

Category: Intracerebral sensor catheter, short-term

Cleared under the same submission (K002765)

and 6 more cleared under K002765

Similar devices

Other devices filed under FDA product code GWM (DEVICE, MONITORING, INTRACRANIAL PRESSURE).

Other devices from Integra LifeSciences Switzerland Sàrl

See all devices from Integra LifeSciences Switzerland Sàrl →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)