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

Illuminator, Fiberoptic, Surgical Field

21 CFR 878.4580 / General, Plastic Surgery
FDA source (opens on fda.gov)

HBI is the FDA product code for Illuminator, Fiberoptic, Surgical Field, a class II device type, regulated under 21 CFR 878.4580. As of , FDA records hold 28 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HBI
Device name
Illuminator, Fiberoptic, Surgical Field
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
28
Ingested recalls
0

Clearances, product code HBI

By decision year
28 clearances under product code HBI with a decision year between 1981 and 2023, 1988 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code HBI by decision year
YearClearances
19812
19851
19861
19885
19891
19904
19911
19924
19931
19981
19991
20021
20051
20111
20151
20161
20231

Applicants with the most clearances

Product code HBI
Applicants holding the most 510(k) clearances under product code HBI
ApplicantClearances
Advanced Surgical Products, Inc.4
Storz Instrument Co.3
Aspen Laboratories, Inc.2
Isolux, LLC2
Nextec Corp.2
Progressive Dynamics, Inc.2
Vital Metrics, Inc.2
Burton Corporation1
Cuda Products Co.1
Endomedix1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 20 companies shown, in name order