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

Dress, Surgical

21 CFR 878.4040 / General, Plastic Surgery
FDA source (opens on fda.gov)

FYE is the FDA product code for Dress, Surgical, a class I device type, regulated under 21 CFR 878.4040. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
FYE
Device name
Dress, Surgical
Regulation
21 CFR 878.4040
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
1

Clearances, product code FYE

By decision year
7 clearances under product code FYE with a decision year between 1989 and 1994, 1989 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code FYE by decision year
YearClearances
19893
19913
19941

Applicants with the most clearances

Product code FYE
Applicants holding the most 510(k) clearances under product code FYE
ApplicantClearances
Barrier Concepts, Inc.1
Clinitech, Inc.1
Depuy-Raynham1
Intermedics Orthopedics1
Johnson & Johnson MEDICAL GmbH1
Protect Corp. of Indiana, Inc.1
Unicor Federal Dept. of Justice1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 118 companies shown, in name order