K163565 is an FDA 510(k) clearance for the MR8 Drill System. This device is classified as a Motor, Drill, Electric (Class II - Special Controls, product code HBC).
Submitted by Medtronic Powered Surgical Solutions (Fort Worth, US). The FDA issued a Cleared decision on March 28, 2017, 99 days after receiving the submission on December 19, 2016.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4360.
| 510(k) Number | K163565 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2016 |
| Decision Date | March 28, 2017 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBC - Motor, Drill, Electric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4360 |