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

Suit, Surgical

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

FXO is the FDA product code for Suit, Surgical, a class I device type, regulated under 21 CFR 878.4040. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FXO
Device name
Suit, 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
6
Ingested recalls
0

Clearances, product code FXO

By decision year
6 clearances under product code FXO with a decision year between 1982 and 1992, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FXO by decision year
YearClearances
19821
19831
19871
19881
19891
19921

Applicants with the most clearances

Product code FXO
Applicants holding the most 510(k) clearances under product code FXO
ApplicantClearances
A Plus International, Inc1
Btp Industries, Inc.1
Kimberly-Clark Corporation1
Pro-Safe Professional Linens, Inc.1
Surgilite Intl., Inc.1
Ulti-Med Intl., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 114 companies shown, in name order