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

Lamp, Surgical, Incandescent

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

GBC is the FDA product code for Lamp, Surgical, Incandescent, a class II device type, regulated under 21 CFR 878.4580. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GBC
Device name
Lamp, Surgical, Incandescent
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code GBC

By decision year
4 clearances under product code GBC with a decision year between 1981 and 1990, 1981 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GBC by decision year
YearClearances
19812
19831
19901

Applicants with the most clearances

Product code GBC
Applicants holding the most 510(k) clearances under product code GBC
ApplicantClearances
Cavitron Corp.1
JEDMED Instrument Company1
Sil-Med Corp.1
Skytron, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code