FDA Product Code FGA: Kit, Nephroscope
Leading manufacturers include Karl Storz SE & CO. KG.
10
Total
10
Cleared
137d
Avg days
1977
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Kit, Nephroscope Devices (Product Code FGA)
10 devices
About Product Code FGA - Regulatory Context
510(k) Submission Activity
10 total 510(k) submissions under product code FGA since 1977, with 10 receiving FDA clearance (average review time: 137 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
FGA devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →