K252514 is an FDA 510(k) clearance for the EVAC-MRI. This device is classified as a Shunt, Central Nervous System And Components (Class II - Special Controls, product code JXG).
Submitted by Phasor Health, LLC (Houston, US). The FDA issued a Cleared decision on November 5, 2025, 86 days after receiving the submission on August 11, 2025.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5550.
| 510(k) Number | K252514 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Direct De Novo (SESD) |
| Date Received | August 11, 2025 |
| Decision Date | November 05, 2025 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | JXG - Shunt, Central Nervous System And Components |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5550 |