K102875 is an FDA 510(k) clearance for the CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT. This device is classified as a Device, Monitoring, Intracranial Pressure (Class II - Special Controls, product code GWM).
Submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on December 20, 2010, 80 days after receiving the submission on October 1, 2010.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1620.
| 510(k) Number | K102875 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 2010 |
| Decision Date | December 20, 2010 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GWM — Device, Monitoring, Intracranial Pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1620 |