K150301 is an FDA 510(k) clearance for the NavSuite3 Kit. This device is classified as a Neurological Stereotaxic Instrument (Class II - Special Controls, product code HAW).
Submitted by Stryker Leibinger GmbH & Co. KG - Navigation (Freiburg, DE). The FDA issued a Cleared decision on July 8, 2015, 152 days after receiving the submission on February 6, 2015.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4560.
| 510(k) Number | K150301 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 2015 |
| Decision Date | July 08, 2015 |
| Days to Decision | 152 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 |