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

Prosthesis, Adhesive, External

21 CFR 878.3750 / General, Plastic Surgery
FDA source (opens on fda.gov)

GBJ is the FDA product code for Prosthesis, Adhesive, External, a class I device type, regulated under 21 CFR 878.3750. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GBJ
Device name
Prosthesis, Adhesive, External
Regulation
21 CFR 878.3750
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
4
Ingested recalls
0

Clearances, product code GBJ

By decision year
4 clearances under product code GBJ with a decision year between 1979 and 1993, 1979 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GBJ by decision year
YearClearances
19792
19811
19931

Applicants with the most clearances

Product code GBJ
Applicants holding the most 510(k) clearances under product code GBJ
ApplicantClearances
Jelco Laboratories1
Minnesota Scientific, Inc.1
Trulife, Inc.1
Whitman Medical Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order