HBE — Drills, Burrs, Trephines & Accessories (Simple, Powered) Class II
FDA product code HBE covers "Drills, Burrs, Trephines & Accessories (Simple, Powered)", a Class II medical device regulated under 21 CFR 882.4310. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HBE
- Device Class
- Class II
- Regulation Number
- 882.4310
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253627 | surgify medical | Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.07 | March 26, 2026 |
| K250815 | hubly | Hubly Drill (H100) | November 6, 2025 |
| K252060 | phasor health | GREEN | October 31, 2025 |
| K252662 | nakanishi | UniBur | September 19, 2025 |
| K251433 | surgify medical | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070 | June 4, 2025 |
| K250380 | surgify medical | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.0 | March 13, 2025 |
| K250374 | stryker instruments | iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision | March 11, 2025 |
| K232684 | surgify medical | Surgify Halo | November 29, 2023 |
| K230619 | hubly | Hubly Electric Drill (H100) | May 4, 2023 |
| K223199 | biomet microfixation | 2.1 x 255mm Drill, 22mm Stop | November 15, 2022 |
| K213072 | biomet micofixation | 2.1 x 255mm Drill, 22mm Stop | August 23, 2022 |
| K213208 | biomet microfixation | Twist Drills | December 23, 2021 |
| K213454 | medtronic powered surgical solutions | Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas | November 23, 2021 |
| K202120 | nakanishi | P300 Attachment | October 22, 2021 |
| K203739 | aesculap | ELAN 4 Electro Motor System | August 24, 2021 |
| K210377 | stryker corporation | Stryker iBur hubs and cutting accessories | June 30, 2021 |
| K191479 | adeor medical | Velocity Alpha Highspeed Surgical Drill System | April 11, 2021 |
| K183203 | aesculap | ELAN 4 Tools | August 9, 2019 |
| K183545 | anspach effort | Anspach Helix Dissection Tools | July 19, 2019 |
| K191049 | stryker corporation | Stryker MIS and Footed Attachments | June 18, 2019 |