FDA Product Code HBE: Drills, Burrs, Trephines & Accessories (simple, Powered)
Under FDA product code HBE, neurosurgical drills, burrs, and trephines are cleared for bone removal and shaping during intracranial and spinal procedures.
These powered or manual cutting instruments are used to perform craniotomies, drill burr holes, remove bone flaps, and shape bony surfaces during neurosurgical procedures. High-speed pneumatic or electric drills with irrigating systems minimize thermal injury to surrounding neural tissue.
HBE devices are Class II medical devices, regulated under 21 CFR 882.4310 and reviewed by the FDA Neurology panel.
Leading manufacturers include Aesculap, Inc., Surgify Medical OY and Stryker Corporation.
65
Total
65
Cleared
136d
Avg days
1987
Since
Growing category -
7 submissions in the last 2 years
vs 4 in the prior period
Review times improving: avg
85d
recently vs 142d historically
FDA 510(k) Cleared Drills, Burrs, Trephines & Accessories (simple, Powered) Devices (Product Code HBE)
65 devices
Cleared
Mar 26, 2026
Surgify Halo (54.085.SHD.U1)
Surgify Medical OY
Neurology
127d
Cleared
Nov 06, 2025
Hubly Drill (H100)
Hubly, Inc.
Neurology
234d
Cleared
Oct 31, 2025
GREEN
Phasor Health, LLC
Neurology
122d
Cleared
Sep 19, 2025
UniBur
Nakanishi, Inc.
Neurology
28d
Cleared
Jun 04, 2025
Surgify Halo (54.085.SHD.H1)
Surgify Medical OY
Neurology
27d
Cleared
Mar 13, 2025
Surgify Halo (54.085.SHD.H1)
Surgify Medical OY
Neurology
30d
Cleared
Mar 11, 2025
iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D)
Stryker Instruments
Neurology
29d
Cleared
Nov 29, 2023
Surgify Halo
Surgify Medical OY
Neurology
89d
Cleared
May 04, 2023
Hubly Electric Drill (H100)
Hubly, Inc.
Neurology
59d
Cleared
Nov 15, 2022
2.1 x 255mm Drill, 22mm Stop
Biomet Microfixation
Neurology
33d
Cleared
Aug 23, 2022
2.1 x 255mm Drill, 22mm Stop
Biomet Micofixation
Neurology
334d
Cleared
Dec 23, 2021
Twist Drills
Biomet Microfixation
Neurology
85d
Cleared
Nov 23, 2021
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
Neurology
28d
Cleared
Oct 22, 2021
P300 Attachment
Nakanishi, Inc.
Neurology
449d
Cleared
Aug 24, 2021
ELAN 4 Electro Motor System
Aesculap, Inc.
Neurology
245d
Cleared
Jun 30, 2021
Stryker iBur hubs and cutting accessories
Stryker Corporation
Neurology
141d
Cleared
Apr 11, 2021
Velocity Alpha Highspeed Surgical Drill System
Adeor Medical AG
Neurology
677d
Cleared
Aug 09, 2019
ELAN 4 Tools
Aesculap, Inc.
Neurology
263d
Cleared
Jul 19, 2019
Anspach Helix Dissection Tools
The Anspach Effort, Inc.
Neurology
211d
Cleared
Jun 18, 2019
Stryker MIS and Footed Attachments
Stryker Corporation
Neurology
60d
Cleared
Jun 14, 2019
Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
Stryker
Neurology
133d
Cleared
Jan 19, 2019
ELAN 4 Tools
Aesculap, Inc.
Neurology
127d
Cleared
Oct 17, 2018
ELAN 4 Electro Motor System Tools
Aesculap, Inc.
Neurology
404d
Cleared
Oct 04, 2018
POWEREASE System
Medtronic Sofamor Danek USA, Inc.
Neurology
27d
About Product Code HBE - Regulatory Context
510(k) Submission Activity
65 total 510(k) submissions under product code HBE since 1987, with 65 receiving FDA clearance (average review time: 136 days).
Submission volume has increased in recent years - 7 submissions in the last 24 months compared to 4 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - HBE Product Code
Recent submissions under HBE have taken an average of 85 days to reach a decision - down from 142 days historically, suggesting improved FDA processing for this classification.
HBE devices are reviewed by the Neurology panel. Browse all Neurology devices →