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

Camera, Still, Endoscopic

21 CFR 878.4160 / General, Plastic Surgery
FDA source (opens on fda.gov)

FXM is the FDA product code for Camera, Still, Endoscopic, a class I device type, regulated under 21 CFR 878.4160. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and 5 recalls.

Classification record

Product code
FXM
Device name
Camera, Still, Endoscopic
Regulation
21 CFR 878.4160
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
5

Clearances, product code FXM

By decision year
1 clearance under product code FXM with a decision year between 1982 and 1982, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FXM by decision year
YearClearances
19821

Applicants with the most clearances

Product code FXM
Applicants holding the most 510(k) clearances under product code FXM
ApplicantClearances
Kelleher Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order