HBE
- Product code
- HBE
- Device name
- Drills, Burrs, Trephines & Accessories (Simple, Powered)
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.4310
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 8
- Summaries archived here
- 8 (direct download)
- 510(k) clearances (all years, FDA)
- 65 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (8)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253627 | 2026-03-26 | Surgify Medical OY | Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.S… | |
| K250815 | 2025-11-06 | Hubly, Inc. | Hubly Drill (H100) | |
| K252060 | 2025-10-31 | Phasor Health, LLC | GREEN | |
| K252662 | 2025-09-19 | Nakanishi, Inc. | UniBur | |
| K251433 | 2025-06-04 | Surgify Medical OY | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.S… | |
| K250380 | 2025-03-13 | Surgify Medical OY | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140… | |
| K250374 | 2025-03-11 | Stryker Instruments | iBur 3.0mm Diamond Match Head, Distal Bend (8431-107… | |
| K232684 | 2023-11-29 | Surgify Medical OY | Surgify Halo |
Official FDA classification page: HBE
Classification and pathway per current FDA publications. Data from openFDA (CC0).