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

Tape, Camera, Surgical

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

FXN is the FDA product code for Tape, Camera, Surgical, a class I device type, regulated under 21 CFR 878.4160. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FXN
Device name
Tape, Camera, Surgical
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
4
Ingested recalls
0

Clearances, product code FXN

By decision year
4 clearances under product code FXN with a decision year between 1996 and 2013, 2013 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FXN by decision year
YearClearances
19961
20071
20132

Applicants with the most clearances

Product code FXN
Applicants holding the most 510(k) clearances under product code FXN
ApplicantClearances
Advanced Planimetric Services, LLC1
Aranz Medical Limited1
Verg, Inc.1
WoundVision, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 26 companies shown, in name order