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

Marker, Skin

21 CFR 878.4660 / General, Plastic Surgery
FDA source (opens on fda.gov)

FZZ is the FDA product code for Marker, Skin, a class I device type, regulated under 21 CFR 878.4660. As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
FZZ
Device name
Marker, Skin
Regulation
21 CFR 878.4660
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
23
Ingested recalls
2

Clearances, product code FZZ

By decision year
23 clearances under product code FZZ with a decision year between 1977 and 2004, 1984 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code FZZ by decision year
YearClearances
19771
19782
19791
19821
19833
19844
19851
19863
19891
19901
19912
19922
20041

Applicants with the most clearances

Product code FZZ
Applicants holding the most 510(k) clearances under product code FZZ
ApplicantClearances
Devon Industries, Inc.2
Precision Dynamics Corporation2
Abco Dealers, Inc.1
Accu-Line1
Aesculap Inc1
Alphamedix, Inc.1
American Medical Mfg., Inc.1
Dermacare Products, Inc.1
E.M. Adams Co., Inc.1
Freckles Publications, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 173 companies shown, in name order