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

Drills, Burrs, Trephines & Accessories (Manual)

21 CFR 882.4300 / Neurology
FDA source (opens on fda.gov)

HBG is the FDA product code for Drills, Burrs, Trephines & Accessories (Manual), a class II device type, regulated under 21 CFR 882.4300. As of , FDA records hold 17 510(k) clearances under this code, the most recent dated , and 54 recalls.

Classification record

Product code
HBG
Device name
Drills, Burrs, Trephines & Accessories (Manual)
Regulation
21 CFR 882.4300
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
17
Ingested recalls
54

Clearances, product code HBG

By decision year
17 clearances under product code HBG with a decision year between 1986 and 2025, 1990 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HBG by decision year
YearClearances
19861
19871
19881
19891
19902
19911
19931
19961
20022
20131
20151
20161
20172
20251

Applicants with the most clearances

Product code HBG
Applicants holding the most 510(k) clearances under product code HBG
ApplicantClearances
Mri Interventions, Inc.3
Neurodynamics, Inc.2
Pudenz-Schulte Medical Research Corp.2
Camino Laboratories, Inc.1
Clinical Neuro Systems, LLC1
Medical Design, LLC1
Medtronic Xomed, Inc.1
Phasor Health, LLC1
Ruggles Corp.1
Solway, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 53 companies shown, in name order