HBG
- Product code
- HBG
- Device name
- Drills, Burrs, Trephines & Accessories (Manual)
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.4300
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 17
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name |
|---|---|---|---|
| K252696 | 2025-11-21 | Phasor Health, LLC | LEGACY summary |
Official FDA classification page: HBG
Classification and pathway per current FDA publications. Data from openFDA (CC0).