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

Specula Accessories

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

FXG is the FDA product code for Specula Accessories, 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 one recall.

Classification record

Product code
FXG
Device name
Specula Accessories
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
1

Clearances, product code FXG

By decision year
1 clearance under product code FXG with a decision year between 1989 and 1989, 1989 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FXG by decision year
YearClearances
19891

Applicants with the most clearances

Product code FXG
Applicants holding the most 510(k) clearances under product code FXG
ApplicantClearances
Semantodontics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 35 companies shown, in name order