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

Catheter, Ureteral Disposable (X-Ray)

21 CFR 876.5130 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FGF is the FDA product code for Catheter, Ureteral Disposable (X-Ray), a class II device type, regulated under 21 CFR 876.5130. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
FGF
Device name
Catheter, Ureteral Disposable (X-Ray)
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code FGF

By decision year
1 clearance under product code FGF with a decision year between 1990 and 1990, 1990 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FGF by decision year
YearClearances
19901

Applicants with the most clearances

Product code FGF
Applicants holding the most 510(k) clearances under product code FGF
ApplicantClearances
Applied Urology, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code FGF.