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

Material, External Aesthetic Restoration, Used With Adhesive

21 CFR 878.3800 / General, Plastic Surgery
FDA source (opens on fda.gov)

GBI is the FDA product code for Material, External Aesthetic Restoration, Used With Adhesive, a class I device type, regulated under 21 CFR 878.3800. As of , FDA records hold 17 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GBI
Device name
Material, External Aesthetic Restoration, Used With Adhesive
Regulation
21 CFR 878.3800
Device class
Class I
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
17
Ingested recalls
0

Clearances, product code GBI

By decision year
17 clearances under product code GBI with a decision year between 1977 and 1988, 1983 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code GBI by decision year
YearClearances
19771
19791
19821
19834
19843
19852
19874
19881

Applicants with the most clearances

Product code GBI
Applicants holding the most 510(k) clearances under product code GBI
ApplicantClearances
MEDLINE INDUSTRIES, LP - Northfield3
Delaware Prosthetics, Inc.3
Allan V. Marse1
Baurs Krey Assoc., Inc.1
Beiersdorf, Inc.1
Factor, II, Inc.1
Ipos KG1
Medeering, Ltd.1
Pacific Prosthetics, Inc.1
Roseburg SA1

Companies listing this code with FDA

Companies whose registered establishments list this code