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

Motor, Drill, Electric

21 CFR 882.4360 / Neurology
FDA source (opens on fda.gov)

HBC is the FDA product code for Motor, Drill, Electric, a class II device type, regulated under 21 CFR 882.4360. As of , FDA records hold 26 510(k) clearances under this code, the most recent dated , and 39 recalls.

Classification record

Product code
HBC
Device name
Motor, Drill, Electric
Regulation
21 CFR 882.4360
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
39

Clearances, product code HBC

By decision year
27 clearances under product code HBC with a decision year between 1981 and 2026, 2001 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code HBC by decision year
YearClearances
19811
19861
19981
20001
20014
20021
20062
20081
20091
20132
20141
20161
20172
20181
20191
20211
20222
20242
20261

Applicants with the most clearances

Product code HBC
Applicants holding the most 510(k) clearances under product code HBC
ApplicantClearances
Aesculap Inc3
Medtronic Powered Surgical Solutions3
The Anspach Effort, Inc.3
Bien-Air Surgery SA2
Linvatec Corporation2
Nakanishi Inc.2
Saeshin Precision Co., Ltd.2
Sodemsystems2
Bioplate Inc1
Black & Decker(Tm)1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 42 companies shown, in name order