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

Splint, Extremity, Inflatable, External

21 CFR 878.3900 / General, Plastic Surgery
FDA source (opens on fda.gov)

FZF is the FDA product code for Splint, Extremity, Inflatable, External, a class I device type, regulated under 21 CFR 878.3900. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FZF
Device name
Splint, Extremity, Inflatable, External
Regulation
21 CFR 878.3900
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
7
Ingested recalls
0

Clearances, product code FZF

By decision year
7 clearances under product code FZF with a decision year between 1983 and 1988, 1987 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code FZF by decision year
YearClearances
19831
19851
19874
19881

Applicants with the most clearances

Product code FZF
Applicants holding the most 510(k) clearances under product code FZF
ApplicantClearances
Vinyl Technology, Inc.4
Hospitak, Inc.1
R. Evans Corp.1
Svenol Andersen1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 51 companies shown, in name order