K132436 is an FDA 510(k) clearance for the VARIOGUIDE DRILL KIT. This device is classified as a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II - Special Controls, product code HBE).
Submitted by Mri Interventions, Inc. (Irvine, US). The FDA issued a Cleared decision on March 20, 2014, 227 days after receiving the submission on August 5, 2013.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4310.
| 510(k) Number | K132436 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2013 |
| Decision Date | March 20, 2014 |
| Days to Decision | 227 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBE - Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4310 |