K201175 is an FDA 510(k) clearance for the StealthStation Cranial Software v1.3.0. This device is classified as a Neurological Stereotaxic Instrument (Class II - Special Controls, product code HAW).
Submitted by Medtronic Navigation, Inc. (Louisville, US). The FDA issued a Cleared decision on June 3, 2020, 33 days after receiving the submission on May 1, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4560.
| 510(k) Number | K201175 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2020 |
| Decision Date | June 03, 2020 |
| Days to Decision | 33 days |
| Submission Type | Special |
| 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 |