510(k) K053244 ยท GWM Device, Monitoring, Intracranial Pressure
LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT
| Applicant | Integra Lifesciences Corp., Plainsboro NJ, US |
| Decision | Substantially Equivalent, May 10, 2006 |
| Received | Nov 21, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053244
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2014 | Integra LifeSciences Corp. Integra Licox Brain Tissue Oxygen Monitoring
Integra Licox Recon Tissue Oxygen Monitoring
1) LICOX Complete Brain Probe Kit (comprised of IP1, CC1.P1)
2) LICOX Complete Brain Probe Kit (comprised of Terminated |
GWM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.