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

Catheter, Retention, Barium Enema With Bag

21 CFR 876.5980 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FGD is the FDA product code for Catheter, Retention, Barium Enema With Bag, a class II device type, regulated under 21 CFR 876.5980. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FGD
Device name
Catheter, Retention, Barium Enema With Bag
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
0

Clearances, product code FGD

By decision year
6 clearances under product code FGD with a decision year between 1987 and 2023, 1991 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FGD by decision year
YearClearances
19871
19891
19901
19912
20231

Applicants with the most clearances

Product code FGD
Applicants holding the most 510(k) clearances under product code FGD
ApplicantClearances
E-Z-EM, Inc2
Chess Medical Inc.1
Lafayette Pharmacal, Inc.1
Mac Lee Medical Products1
Mmi, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order