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

Strip, Adhesive, Closure, Skin

21 CFR 880.5240 / General Hospital
FDA source (opens on fda.gov)

FPX is the FDA product code for Strip, Adhesive, Closure, Skin, a class I device type, regulated under 21 CFR 880.5240. As of , FDA records hold 35 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
FPX
Device name
Strip, Adhesive, Closure, Skin
Regulation
21 CFR 880.5240
Device class
Class I
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
35
Ingested recalls
1

Clearances, product code FPX

By decision year
35 clearances under product code FPX with a decision year between 1977 and 1997, 1980 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code FPX by decision year
YearClearances
19776
19782
19793
19808
19821
19833
19843
19881
19891
19901
19921
19931
19953
19971

Applicants with the most clearances

Product code FPX
Applicants holding the most 510(k) clearances under product code FPX
ApplicantClearances
Johnson & Johnson Professionals, Inc.7
Beiersdorf, Inc.6
American Medical Disposable, Inc.2
Shur Medical Corp.2
Abbott Medical1
Acme United Corp.1
American White Cross, Inc.1
Bitco Intl.1
Cornelia Damsky, Inc.1
Devon Industries, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 30 companies shown, in name order