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

Cover, Shoe, Operating-Room

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

FXP is the FDA product code for Cover, Shoe, Operating-Room, a class I device type, regulated under 21 CFR 878.4040. As of , FDA records hold 36 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FXP
Device name
Cover, Shoe, Operating-Room
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
36
Ingested recalls
0

Clearances, product code FXP

By decision year
36 clearances under product code FXP with a decision year between 1976 and 1998, 1980 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code FXP by decision year
YearClearances
19762
19781
19804
19831
19841
19852
19864
19873
19884
19892
19911
19932
19941
19953
19962
19972
19981

Applicants with the most clearances

Product code FXP
Applicants holding the most 510(k) clearances under product code FXP
ApplicantClearances
Abco Dealers, Inc.3
James River Corp.3
Amerasia Corp.2
Procter & Gamble Mfg. Co.2
Tecnol New Jersey Wound Care, Inc.2
A Plus International, Inc1
Medtronic, Inc.1
American Convertors Div., American Pharmaseal1
American Threshold Industries, Inc.1
Amsco Sterile Recoveries, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 281 companies shown, in name order