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

Mallet, Surgical, General & Plastic Surgery

21 CFR 878.4800 / General, Plastic Surgery
FDA source (opens on fda.gov)

GFJ is the FDA product code for Mallet, Surgical, General & Plastic Surgery, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
GFJ
Device name
Mallet, Surgical, General & Plastic Surgery
Regulation
21 CFR 878.4800
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
3
Ingested recalls
2

Clearances, product code GFJ

By decision year
3 clearances under product code GFJ with a decision year between 1982 and 1985, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GFJ by decision year
YearClearances
19821
19841
19851

Applicants with the most clearances

Product code GFJ
Applicants holding the most 510(k) clearances under product code GFJ
ApplicantClearances
Artiberia1
Kelleher Corp.1
Rabar, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 168 companies shown, in name order