HBE · Class II · 21 CFR 882.4310

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 The Anspach Effort, Inc., Aesculap, Inc. and Surgify Medical OY.

65
Total
65
Cleared
136d
Avg days
1987
Since
65 devices
25–48 of 65
Cleared Sep 07, 2017
Cranial Drill Bits and Accessories
K170442
Ad-Tech Medical Instrument Corporation
Neurology · 205d
Cleared May 19, 2017
OsteoMed PINNACLE Driver
K162542
Osteomed
Neurology · 249d
Cleared Dec 01, 2016
Phasor Drill
K161704
Biotex, Inc.
Neurology · 164d
Cleared Mar 16, 2016
DReal
K153519
Carevature Medical, Ltd.
Neurology · 99d
Cleared May 08, 2015
Stryker Footed Attachments and Cutting Accessories
K143399
Stryker Corp.
Neurology · 161d
Cleared May 01, 2015
Stryker MIS Attachments and Cutting Accessories
K143540
Stryker Corporation
Neurology · 137d
Cleared Apr 23, 2015
Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
K143320
Stryker Corp.
Neurology · 155d
Cleared Jun 27, 2014
HICUT HIGHSPEED INSTRUMENT
K130755
Adeor Medical AG
Neurology · 465d
Cleared Mar 20, 2014
VARIOGUIDE DRILL KIT
K132436
Mri Interventions, Inc.
Neurology · 227d
Cleared Jan 11, 2013
POWEREASE SYSTEM
K123270
Medtronic Sofamor Danek USA, Inc.
Neurology · 84d
Cleared Aug 27, 2012
TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE
K121264
Medtronic Surgical Technologies
Neurology · 123d
Cleared Dec 16, 2011
ANSPACH DISSECTION TOOLS
K113476
The Anspach Effort, Inc.
Neurology · 24d
Cleared Oct 26, 2011
IPC POWEREASE SYSTEM
K111520
Medtronic Xomed, Inc.
Neurology · 146d
Cleared Oct 17, 2008
ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]
K081475
Medtronic Xomed, Inc.
Neurology · 143d
Cleared Apr 30, 2008
EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL
K080802
The Anspach Effort, Inc.
Neurology · 40d
Cleared Dec 04, 2006
TWIST DRILL
K062842
Walter Lorenz Surgical, Inc.
Neurology · 73d
Cleared Apr 07, 2005
ANSPACH COUPLER
K050628
The Anspach Effort, Inc.
Neurology · 27d
Cleared Dec 17, 2004
ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM
K042783
The Anspach Effort, Inc.
Neurology · 72d
Cleared Mar 15, 2004
ANSPACH ADVANCED MICRO SAW ATTACHMENTS
K040076
The Anspach Effort, Inc.
Neurology · 61d
Cleared Jan 16, 2004
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
K032303
Stryker Instruments
Neurology · 175d
Cleared Oct 21, 2002
CRANIOCUT
K022942
Aesculap, Inc.
Neurology · 46d
Cleared Oct 24, 2000
ANSPACH ANGLED MICRONOSE ATTACHMENT
K002903
The Anspach Effort, Inc.
Neurology · 36d
Cleared Jun 03, 1999
XK-95 HIGH SPEED MOTOR DRILL SYSTEM
K984035
Komet Medical
Neurology · 203d
Cleared May 18, 1995
75K STAIGHT DRILL
K943541
Stryker Corp.
Neurology · 300d