K250815 is an FDA 510(k) clearance for the Hubly Drill (H100). This device is classified as a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II - Special Controls, product code HBE).
Submitted by Hubly, Inc. (Lisle, US). The FDA issued a Cleared decision on November 6, 2025, 234 days after receiving the submission on March 17, 2025.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4310.
| 510(k) Number | K250815 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 2025 |
| Decision Date | November 06, 2025 |
| Days to Decision | 234 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 |