K160129 is an FDA 510(k) clearance for the MRII Cranial Drill and Accessories. This device is classified as a Drills, Burrs, Trephines & Accessories (manual) (Class II - Special Controls, product code HBG).
Submitted by Mri Interventions, Inc. (Irvine, US). The FDA issued a Cleared decision on March 26, 2016, 66 days after receiving the submission on January 20, 2016.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4300.
| 510(k) Number | K160129 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 20, 2016 |
| Decision Date | March 26, 2016 |
| Days to Decision | 66 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBG - Drills, Burrs, Trephines & Accessories (manual) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4300 |