HBF
- Product code
- HBF
- Device name
- Drills, Burrs, Trephines & Accessories (Compound, Powered)
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.4305
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 0 (direct download)
- 510(k) clearances (all years, FDA)
- 18 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K231403 | 2024-03-06 | Evonos GmbH & Co. KG | evoDrill Cranial Perforator | FDA |
Official FDA classification page: HBF
Classification and pathway per current FDA publications. Data from openFDA (CC0).