510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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HBFClass II

Drills, Burrs, Trephines & Accessories (Compound, Powered)

21 CFR 882.4305 / Neurology
FDA source (opens on fda.gov)

HBF is the FDA product code for Drills, Burrs, Trephines & Accessories (Compound, Powered), a class II device type, regulated under 21 CFR 882.4305. As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
HBF
Device name
Drills, Burrs, Trephines & Accessories (Compound, Powered)
Regulation
21 CFR 882.4305
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
19
Ingested recalls
6

Clearances, product code HBF

By decision year
19 clearances under product code HBF with a decision year between 1979 and 2026, 2008 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code HBF by decision year
YearClearances
19791
19821
19831
19881
19891
19932
19981
20031
20071
20083
20121
20151
20191
20221
20241
20261

Applicants with the most clearances

Product code HBF
Applicants holding the most 510(k) clearances under product code HBF
ApplicantClearances
Cerenovus, Inc.6
Acra Cut, Inc.3
The Anspach Effort, Inc.2
Adeor Medical Technologies GmbH1
EMD Endoszkop Muszer Gyarto ES Kereskedelmi Kft.1
Evonos GmbH & Co. KG1
Guizhou Zirui Technology Co., Ltd.1
Integra LifeSciences Corporation1
Micromar Ind. Com., Ltd.1
Neurodynamics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 26 companies shown, in name order