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Licox® PMOCAB

by Integra Lifesciences (Ireland) Limited

Part of a family of 24 devices: see the family page

Ref PMOCAB

Licox® PMOCAB is a device classified as Class I in the EU and Class II in the US made by Integra Lifesciences (Ireland) Limited, registered in EUDAMED on 8 Jul 2026 (Basic UDI-DI 038178B0036CSS3D), cleared under FDA 510(k) K040235 on 20 Apr 2004 and listed in FDA GUDID since 2 Aug 2016 (UDI-DI 10381780250043), active as of 24 Oct 2026. 12 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

12 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K040235

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number038178B0036CSS3D Basic UDI-DI 10381780250043UDI-DIDate8 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780250043 UDI-DI Date2 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK040235 Date20 Apr 2004DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 038178B0036CSS3D registered 8 Jul 2026 Active
  • FDA 510(k) K040235 decided 20 Apr 2004 Active
  • FDA GUDID UDI-DI 10381780250043 listed 2 Aug 2016 Listed

Recalls

12 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.

  • 9 recalls, same reason

    • Terminated Z-0061-2014 FDA Class II initiated 11 Jun 2013
    • Terminated Z-0056-2014 FDA Class II initiated 11 Jun 2013
    • Terminated Z-0062-2014 FDA Class II initiated 11 Jun 2013
    • Terminated Z-0063-2014 FDA Class II initiated 11 Jun 2013
    • Terminated Z-0060-2014 FDA Class II initiated 11 Jun 2013
    • Terminated Z-0057-2014 FDA Class II initiated 11 Jun 2013
    • Terminated Z-0055-2014 FDA Class II initiated 11 Jun 2013
    • Terminated Z-0054-2014 FDA Class II initiated 11 Jun 2013
    • Terminated Z-0059-2014 FDA Class II initiated 11 Jun 2013

    Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.

    • Terminated Z-0161-2011 FDA Unclassified (pre-2012) initiated 15 Sep 2010

    Incorrect expiration date - The outer boxes of the IP2P Licox Complete Kit for Cerebral Pressure, Temperature and ICP Monitoring Probes, Lot 250210A are labeled with an incorrect shelf life date (10 months too long).

    • Terminated Z-1422-2010 FDA Unclassified (pre-2012) initiated 18 Feb 2010

    One probe that had failed a product release test was inadvertently packaged and released into inventory in Integra's distribution center.

Timeline

15 dated events

  1. Recall initiated FDA recalls Z-0062-2014
  2. Recall initiated FDA recalls Z-0063-2014
  3. Recall initiated FDA recalls Z-0060-2014
  4. Recall initiated FDA recalls Z-0057-2014
  5. Recall initiated FDA recalls Z-0055-2014
  6. Recall initiated FDA recalls Z-0054-2014
  7. Recall initiated FDA recalls Z-0059-2014
  8. Recall initiated FDA recalls Z-0831-2015
  9. Listed FDA GUDID 10381780250043
  10. Registered EUDAMED 038178B0036CSS3D

5 earlier events are in the sections above.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Licox®
Generic name
Electrical-only medical device connection cable, reusable
Device name
lntegra Monitor cables
Model / Ref / Catalog
PMOCAB
Primary DI / UDI-DI
10381780250043
Basic UDI-DI
038178B0036CSS3D
Direct marketing DI
10381780250043
FDA product code
GWM
EMDN code
L99 Surgical instruments, reusable - other
GMDN term
Electrical-only medical device connection cable, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.1620
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Electrical-only medical device connection cable, reusable

Cleared under the same submission (K040235)

and 2 more cleared under K040235

Similar devices in this category

Other devices filed under SURGICAL INSTRUMENTS, REUSABLE - OTHER.

Other devices from Integra Lifesciences (Ireland) Limited

See all devices from Integra Lifesciences (Ireland) Limited →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)