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

Shoes, Operating-Room

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

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

Classification record

Product code
FXW
Device name
Shoes, 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
1
Ingested recalls
0

Clearances, product code FXW

By decision year
1 clearance under product code FXW with a decision year between 1993 and 1993, 1993 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FXW by decision year
YearClearances
19931

Applicants with the most clearances

Product code FXW
Applicants holding the most 510(k) clearances under product code FXW
ApplicantClearances
Dynatech Medical Products1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order