HBF · Class II · 21 CFR 882.4305

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

Leading manufacturers include Codman & Shurtleff, Inc., Integra Lifesciences Corp. and Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft..

18
Total
18
Cleared
125d
Avg days
1979
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

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

18 devices
1–18 of 18
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 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 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

18 total 510(k) submissions under product code HBF since 1979, with 18 receiving FDA clearance (average review time: 125 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.