FDA Product Code FGD: Catheter, Retention, Barium Enema With Bag
Leading manufacturers include Chess Medical, Inc..
6
Total
6
Cleared
166d
Avg days
1987
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Catheter, Retention, Barium Enema With Bag Devices (Product Code FGD)
6 devices
About Product Code FGD - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code FGD since 1987, with 6 receiving FDA clearance (average review time: 166 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
FGD devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →