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

Appliance, Facial Fracture, External

21 CFR 878.3250 / General, Plastic Surgery
FDA source (opens on fda.gov)

FYI is the FDA product code for Appliance, Facial Fracture, External, a class I device type, regulated under 21 CFR 878.3250. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FYI
Device name
Appliance, Facial Fracture, External
Regulation
21 CFR 878.3250
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 FYI

By decision year
4 clearances under product code FYI with a decision year between 1979 and 1987, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FYI by decision year
YearClearances
19791
19801
19831
19871

Applicants with the most clearances

Product code FYI
Applicants holding the most 510(k) clearances under product code FYI
ApplicantClearances
Conphar, Inc.1
Ethicon, Inc1
Omega Silicone, Inc.1
Surgical Technology Laboratories Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code