510(k) K040235 ยท GWM Device, Monitoring, Intracranial Pressure
LICOX PMO BRAIN MONITORING SYSTEM
| Applicant | Integra LifeSciences Corporation, Planisboro NJ, US |
| Decision | Substantially Equivalent, Apr 20, 2004 |
| Received | Feb 2, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040235
| 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 |
| Oct 23, 2013 | Integra LifeSciences Corp. Integra Licox Brain Tissue Oxygen Monitoring; 1 x Complete Brain Probe Kit
REF IP1.P
Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Terminated |
GWM | None listed |
| Oct 23, 2013 | Integra LifeSciences Corp. Integra Licox Brain Tissue Oxygen Monitoring; 1 x Dual Lumen Introducer Kit
REF IP2; Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Terminated |
GWM | None listed |
| Oct 23, 2013 | Integra LifeSciences Corp. Integra Licox Brain Tissue Oxygen Monitoring
1 x Complete Brain Probe Kit
REF IP2.P
Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Terminated |
GWM | None listed |
| Oct 23, 2013 | Integra LifeSciences Corp. Inegra Licox Brain Tissue Oxygen Monitoring
1 x Complete Brain Tunneling Probe Kit
REF IT2
Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Terminated |
GWM | None listed |
| Oct 23, 2013 | Integra LifeSciences Corp. Integra Licox Brain Tissue Oxygen Monitoring
1 x Complete Brain Probe Kit
REF IM1.S
Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germa Terminated |
GWM | None listed |
| Oct 23, 2013 | Integra LifeSciences Corp. Integra Licox Brain Tissue Oxygen Monitoring
1 x Dual Lumen Introducer Kit
REF IM2_EU
Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germa Terminated |
GWM | None listed |
| Oct 23, 2013 | Integra LifeSciences Corp. Integra Licox Brain Tissue Oxygen Monitoring
1 x Dual Lumen Introducer Kit
REF IM2.S_.EU
Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Ge Terminated |
GWM | None listed |
| Oct 23, 2013 | Integra LifeSciences Corp. Integra Licox Brain Tissue Oxygen Monitoring
1 x Complete Brain Probe Kit
REF IM3.S_.EU
Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Ger Terminated |
GWM | None listed |
| Oct 23, 2013 | Integra LifeSciences Corp. Integra Licox Brain Tissue Oxygen Monitoring
1 x Complete Brain Probe Kit
REF IM3.ST_.EU
Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Ge Terminated |
GWM | None listed |
| Oct 28, 2010 | Integra LifeSciences Corp. Licox Brain PMO Probe Kit;
Ref IP2.P;
Multiparameter Monitoring Oxygen + ICP Channel: Contain Products: REF IP2 Bolt kit for 2 brain probes, Ref CC1.P1 combined Oxygen & Temperature probe;
Contains st Terminated |
GWM | None listed |
| Apr 20, 2010 | Integra LifeSciences Corp. Integra, Licox Ref 1P2.P;
Brain PMO-Probe Kit
Rx only; Contains Products: REF 1P2 Bolt kit for 2 Brain probes,
REF CC1/P1 Combined Oxygen & Temperature Probe.
Contents Sterile and Non-Pyrogenic if pa Terminated |
GWM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.