HBF · Class II · 21 CFR 882.4305

FDA Product Code HBF: Drills, Burrs, Trephines & Accessories (compound, Powered)

Leading manufacturers include Codman & Shurtleff, Inc., The Anspach Effort, Inc. and Acra Cut, Inc..

19
Total
19
Cleared
132d
Avg days
1979
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg 262d recently vs 125d historically

FDA 510(k) Cleared Drills, Burrs, Trephines & Accessories (compound, Powered) Devices (Product Code HBF)

19 devices
1–19 of 19
Cleared Sep 11, 2026
Disposable Sterile Skull Drill (LZ)
K254177
Guizhou Zirui Technology Co., Ltd.
Neurology · 262d
Cleared Mar 06, 2024
evoDrill Cranial Perforator
K231403
Evonos GmbH & Co. KG
Neurology · 296d
Cleared Jun 20, 2022
NeuroLine Disposable Cranial Perforator with Hudson end
K213228
Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.
Neurology · 264d
Cleared Jan 20, 2019
Codman Disposable Perforators
K183581
Integra Lifesciences Corp.
Neurology · 30d
Cleared Mar 16, 2015
EASYDRILL AUTOSTOP CRANIAL PERFORATOR
K141455
Micromar Ind. Com. , Ltd.
Neurology · 287d
Cleared Jul 17, 2012
MERIDIAN CRANIAL PERFORATOR
K121253
Adeor Medical Technologies GmbH
Neurology · 83d
Cleared Dec 29, 2008
STRYKER DISPOSABLE CRANIAL PERFORATOR BIT
K082010
Stryker Ireland Ltd., Instruments Division
Neurology · 167d
Cleared Dec 22, 2008
CRANIAL PERFORATOR
K082637
The Anspach Effort, Inc.
Neurology · 103d
Cleared Jan 04, 2008
CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231
K073336
Codman & Shurtleff, Inc.
Neurology · 37d
Cleared Oct 22, 2007
CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223
K071931
Codman & Shurtleff, Inc.
Neurology · 101d
Cleared Dec 08, 2003
ACRA-CUT XPRESS 120
K032970
Acra Cut, Inc.
Neurology · 76d
Cleared Oct 21, 1998
ANSPACH ACCESS CRANIAL PERFORATOR
K982991
The Anspach Effort, Inc.
Neurology · 55d
Cleared Dec 10, 1993
DISPOSABLE PERFORATOR
K933894
Codman & Shurtleff, Inc.
Neurology · 122d
Cleared Jul 08, 1993
DISPOSABLE PERFORATOR
K924242
Codman & Shurtleff, Inc.
Neurology · 318d
Cleared Feb 04, 1982
CODMAN * REUSABLE PERFORATOR
K820087
Codman & Shurtleff, Inc.
Neurology · 22d
Cleared Aug 28, 1979
DISPOSABLE PERFORATORS, JACOBS, HUDSON
K791101
Codman & Shurtleff, Inc.
Neurology · 76d

About Product Code HBF - Regulatory Context

510(k) Submission Activity

19 total 510(k) submissions under product code HBF since 1979, with 19 receiving FDA clearance (average review time: 132 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - HBF Product Code

Recent submissions under HBF have taken an average of 262 days to reach a decision - up from 125 days historically. Manufacturers should account for longer review timelines in current project planning.

HBF devices are reviewed by the Neurology panel. Browse all Neurology devices →