Licox® IP1P
by Integra LifeSciences Switzerland Sàrl
Licox® IP1P is a Class II device made by Integra LifeSciences Switzerland Sàrl, cleared under FDA 510(k) K040235 on 20 Apr 2004 and listed in FDA GUDID since 4 Aug 2016 (UDI-DI 10381780250319), active as of 23 Oct 2026. 12 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10381780250319 | Date4 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK040235 | Date20 Apr 2004 | StatusActive |
Official records
- AccessGUDID record 10381780250319
- FDA 510(k) database K040235
Across registries
- FDA 510(k) K040235 decided 20 Apr 2004 Active
- FDA GUDID UDI-DI 10381780250319 listed 4 Aug 2016 Listed
Recalls
-
- Terminated Z-0831-2015
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-0061-2014
- Terminated Z-0056-2014
- Terminated Z-0062-2014
- Terminated Z-0063-2014
- Terminated Z-0060-2014
- Terminated Z-0057-2014
- Terminated Z-0055-2014
- Terminated Z-0054-2014
- Terminated Z-0059-2014
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
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
One probe that had failed a product release test was inadvertently packaged and released into inventory in Integra's distribution center.
Timeline
- Recall initiated FDA recalls Z-0056-2014
- Recall initiated FDA recalls Z-0062-2014
- Recall initiated FDA recalls Z-0063-2014
- Recall initiated FDA recalls Z-0060-2014
- Recall initiated FDA recalls Z-0057-2014
- Recall initiated FDA recalls Z-0055-2014
- Recall initiated FDA recalls Z-0054-2014
- Recall initiated FDA recalls Z-0059-2014
- Recall initiated FDA recalls Z-0831-2015
- Listed FDA GUDID 10381780250319
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Licox®
- Generic name
- Intracerebral sensor catheter, short-term
- Model / Ref / Catalog
- IP1P
- Primary DI / UDI-DI
- 10381780250319
- 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
Similar devices
Other devices filed under FDA product code GWM (DEVICE, MONITORING, INTRACRANIAL PRESSURE).
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- METATECH INTRACRANIAL PRESSURE MONITORING SYSTEM by Metatech Corp.
- LADD MEDICAL S-2000 by Ladd Research Industries, Inc.
- SYNERGY by Innerspace, Inc.
- LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT by Integra Lifesciences Corp.
- NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT by Neurorecovery, Inc.
- INTRACRANIAL PRESSURE MONITORING KIT 070 by Camino Laboratories, Inc.
- Model 704 by Ivy Biomedical Systems, Inc.
- PHILLY INFANT BOLT by Philadelphia Medical Specialties
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