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

Catheter, Double Lumen Female Urethrographic

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

FGH is the FDA product code for Catheter, Double Lumen Female Urethrographic, 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
FGH
Device name
Catheter, Double Lumen Female Urethrographic
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 FGH

By decision year
1 clearance under product code FGH with a decision year between 1991 and 1991, 1991 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FGH by decision year
YearClearances
19911

Applicants with the most clearances

Product code FGH
Applicants holding the most 510(k) clearances under product code FGH
ApplicantClearances
C.R. Bard Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code

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