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

Motor, Drill, Pneumatic

21 CFR 882.4370 / Neurology
FDA source (opens on fda.gov)

HBB is the FDA product code for Motor, Drill, Pneumatic, a class II device type, regulated under 21 CFR 882.4370. As of , FDA records hold 27 510(k) clearances under this code, the most recent dated , and 18 recalls.

Classification record

Product code
HBB
Device name
Motor, Drill, Pneumatic
Regulation
21 CFR 882.4370
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
27
Ingested recalls
18

Clearances, product code HBB

By decision year
27 clearances under product code HBB with a decision year between 1989 and 2026, 1996 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code HBB by decision year
YearClearances
19891
19963
19972
19982
19993
20001
20023
20042
20051
20061
20071
20091
20102
20151
20171
20181
20261

Applicants with the most clearances

Product code HBB
Applicants holding the most 510(k) clearances under product code HBB
ApplicantClearances
Midas Rex Pneumatic Tools, Inc.3
Sodemsystems3
Stryker Corp.3
The Anspach Effort, Inc.3
Aesculap Inc2
Medtronic Powered Surgical Solutions2
Adeor Medical AG1
Image-Guided Neurologics, Inc.1
Komet Medical1
Medicon, E.G.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 38 companies shown, in name order