FDA Product Code FEO: Lithotriptor, Ultrasonic
Leading manufacturers include E.M.S Electro Medical Systems S.A.
14
Total
14
Cleared
127d
Avg days
1984
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Lithotriptor, Ultrasonic Devices (Product Code FEO)
14 devices
About Product Code FEO - Regulatory Context
510(k) Submission Activity
14 total 510(k) submissions under product code FEO since 1984, with 14 receiving FDA clearance (average review time: 127 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
FEO devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →