HBE · Drills, Burrs, Trephines & Accessories (Simple, Powered)
Neurology · 21 CFR 882.4310 · Class 2
Overview
| Product Code | HBE |
|---|---|
| Device Name | Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| Regulation | 21 CFR 882.4310 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 65)
Showing 20 most recent of 65 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253627 | Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2) | Surgify Medical OY | Mar 26, 2026 | SESE |
| K250815 | Hubly Drill (H100) | Hubly, Inc. | Nov 6, 2025 | SESE |
| K252060 | GREEN | Phasor Health, LLC | Oct 31, 2025 | SESE |
| K252662 | UniBur | Nakanishi, Inc. | Sep 19, 2025 | SESE |
| K251433 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1) | Surgify Medical OY | Jun 4, 2025 | SESE |
| K250380 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1) | Surgify Medical OY | Mar 13, 2025 | SESE |
| K250374 | iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R | Stryker Instruments | Mar 11, 2025 | SESE |
| K232684 | Surgify Halo | Surgify Medical OY | Nov 29, 2023 | SESE |
| K230619 | Hubly Electric Drill (H100) | Hubly, Inc. | May 4, 2023 | SESE |
| K223199 | 2.1 x 255mm Drill, 22mm Stop | Biomet Microfixation | Nov 15, 2022 | SESE |
| K213072 | 2.1 x 255mm Drill, 22mm Stop | Biomet Micofixation | Aug 23, 2022 | SESE |
| K213208 | Twist Drills | Biomet Microfixation | Dec 23, 2021 | SESE |
| K213454 | Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm | Medtronic Powered Surgical Solutions | Nov 23, 2021 | SESE |
| K202120 | P300 Attachment | Nakanishi, Inc. | Oct 22, 2021 | SESE |
| K203739 | ELAN 4 Electro Motor System | Aesculap, Inc. | Aug 24, 2021 | SESE |
| K210377 | Stryker iBur hubs and cutting accessories | Stryker Corporation | Jun 30, 2021 | SESE |
| K191479 | Velocity Alpha Highspeed Surgical Drill System | Adeor Medical AG | Apr 11, 2021 | SESE |
| K183203 | ELAN 4 Tools | Aesculap, Inc. | Aug 9, 2019 | SESE |
| K183545 | Anspach Helix Dissection Tools | The Anspach Effort, Inc. | Jul 19, 2019 | SESE |
| K191049 | Stryker MIS and Footed Attachments | Stryker Corporation | Jun 18, 2019 | SESE |
Top Applicants
- The Anspach Effort, Inc. — 7 clearances
- Aesculap, Inc. — 5 clearances
- Surgify Medical OY — 4 clearances
- Stryker Corp. — 3 clearances
- Stryker Corporation — 3 clearances
