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

Catheter, Urethrographic, Male

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

FGI is the FDA product code for Catheter, Urethrographic, Male, a class II device type, regulated under 21 CFR 876.5130. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FGI
Device name
Catheter, Urethrographic, Male
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
3
Ingested recalls
0

Clearances, product code FGI

By decision year
3 clearances under product code FGI with a decision year between 1981 and 2002, 2002 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FGI by decision year
YearClearances
19811
20022

Applicants with the most clearances

Product code FGI
Applicants holding the most 510(k) clearances under product code FGI
ApplicantClearances
Neoseed Technology,Llc1
Vance Products, Inc.1
Vomed Volzer Medizintechnik GmbH & Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code