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

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

21 CFR 882.4310 / Neurology
FDA source (opens on fda.gov)

HBE is the FDA product code for Drills, Burrs, Trephines & Accessories (Simple, Powered), a class II device type, regulated under 21 CFR 882.4310. As of , FDA records hold 65 510(k) clearances under this code, the most recent dated , and 258 recalls.

Classification record

Product code
HBE
Device name
Drills, Burrs, Trephines & Accessories (Simple, Powered)
Regulation
21 CFR 882.4310
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
65
Ingested recalls
258

Clearances, product code HBE

By decision year
65 clearances under product code HBE with a decision year between 1987 and 2026, 2021 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code HBE by decision year
YearClearances
19871
19883
19904
19912
19921
19931
19941
19951
19991
20001
20022
20031
20043
20051
20061
20072
20082
20112
20121
20131
20142
20153
20162
20172
20182
20195
20216
20222
20232
20256
20261

Applicants with the most clearances

Product code HBE
Applicants holding the most 510(k) clearances under product code HBE
ApplicantClearances
Stryker Corp.9
The Anspach Effort, Inc.7
Aesculap Inc5
Surgify Medical Oy4
Biomet Microfixation3
Acra Cut, Inc.2
Adeor Medical AG2
Hubly, Inc.2
Medtronic Powered Surgical Solutions2
Medtronic Sofamor Danek USA Inc2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 120 companies shown, in name order