K141833 is an FDA 510(k) clearance for the STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION. 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 March 25, 2015, 261 days after receiving the submission on July 7, 2014.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4560.
| 510(k) Number | K141833 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2014 |
| Decision Date | March 25, 2015 |
| Days to Decision | 261 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 |