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

Hood, Surgical

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

FXY is the FDA product code for Hood, Surgical, a class II device type, regulated under 21 CFR 878.4040. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
FXY
Device name
Hood, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
13
Ingested recalls
3

Clearances, product code FXY

By decision year
13 clearances under product code FXY with a decision year between 1976 and 2023, 1990 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code FXY by decision year
YearClearances
19763
19772
19881
19904
20141
20201
20231

Applicants with the most clearances

Product code FXY
Applicants holding the most 510(k) clearances under product code FXY
ApplicantClearances
Biomedical Devices, Inc.2
Sherwood Medical Industries2
Stryker Corp.2
Surgikos, Inc.2
Anago, Inc.1
Chicago Assoc. for Retarded Citizens1
James River Corp.1
The Owenby Co.1
Thi Total Healthcare Innovation GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 23 companies shown, in name order