K231403 is an FDA 510(k) clearance for the evoDrill Cranial Perforator. This device is classified as a Drills, Burrs, Trephines & Accessories (compound, Powered) (Class II - Special Controls, product code HBF).
Submitted by Evonos GmbH & Co. KG (Tuttingen, DE). The FDA issued a Cleared decision on March 6, 2024, 296 days after receiving the submission on May 15, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4305.
| 510(k) Number | K231403 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 2023 |
| Decision Date | March 06, 2024 |
| Days to Decision | 296 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBF - Drills, Burrs, Trephines & Accessories (compound, Powered) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4305 |