K231976 is an FDA 510(k) clearance for the StealthStation Cranial Software, v3.1.5 (9735585). This device is classified as a Neurological Stereotaxic Instrument (Class II - Special Controls, product code HAW).
Submitted by Medtronic Navigation, Inc. (Lafayette, US). The FDA issued a Cleared decision on October 19, 2023, 108 days after receiving the submission on July 3, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4560.
| 510(k) Number | K231976 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2023 |
| Decision Date | October 19, 2023 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HAW — Neurological Stereotaxic Instrument |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |