K935861 is an FDA 510(k) clearance for the MEDNEXT BUR. This device is classified as a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II - Special Controls, product code HBE).
Submitted by Mednext, Inc. (West Point Beach, US). The FDA issued a Cleared decision on May 3, 1994, 151 days after receiving the submission on December 3, 1993.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4310.
| 510(k) Number | K935861 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 1993 |
| Decision Date | May 03, 1994 |
| Days to Decision | 151 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | HBE — Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4310 |