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

Speculum, Illuminated

21 CFR 878.1800 / General, Plastic Surgery
FDA source (opens on fda.gov)

FXF is the FDA product code for Speculum, Illuminated, a class I device type, regulated under 21 CFR 878.1800. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
FXF
Device name
Speculum, Illuminated
Regulation
21 CFR 878.1800
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 FXF

By decision year
1 clearance under product code FXF with a decision year between 1980 and 1980, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FXF by decision year
YearClearances
19801

Applicants with the most clearances

Product code FXF
Applicants holding the most 510(k) clearances under product code FXF
ApplicantClearances
Designs for Vision, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 24 companies shown, in name order