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

Splint, Extremity, Noninflatable, External, Sterile

21 CFR 878.3910 / General, Plastic Surgery
FDA source (opens on fda.gov)

FYH is the FDA product code for Splint, Extremity, Noninflatable, External, Sterile, a class I device type, regulated under 21 CFR 878.3910. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FYH
Device name
Splint, Extremity, Noninflatable, External, Sterile
Regulation
21 CFR 878.3910
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
8
Ingested recalls
0

Clearances, product code FYH

By decision year
8 clearances under product code FYH with a decision year between 1980 and 1993, 1993 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FYH by decision year
YearClearances
19801
19811
19821
19841
19851
19891
19932

Applicants with the most clearances

Product code FYH
Applicants holding the most 510(k) clearances under product code FYH
ApplicantClearances
Johnson & Johnson Professionals, Inc.2
Compression Splint Products, Inc.1
Johnson & Johnson Orthopaedics, Inc.1
Kut-Guard, Inc.1
Mizuho Orthopedic Systems Inc1
The Huxley Instrument Corp.1
Trace Medical Equipment, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 34 companies shown, in name order