K232890 is an FDA 510(k) clearance for the CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845). This device is classified as a Device, Monitoring, Intracranial Pressure (Class II - Special Controls, product code GWM).
Submitted by Integra Lifesciences Production Corporation (Mansfield, US). The FDA issued a Cleared decision on February 4, 2024, 139 days after receiving the submission on September 18, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1620.
| 510(k) Number | K232890 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 2023 |
| Decision Date | February 04, 2024 |
| Days to Decision | 139 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 |