FDA Product Code ODA: Endoscopic Central Control Unit
To Control Endoscopic And Other Ancillary Surgical Equipment In One Central Location, Either By Remote Control, Touch Screen, Or Voice Command.
Leading manufacturers include Karl Storz SE & CO. KG.
18
Total
18
Cleared
134d
Avg days
1998
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Endoscopic Central Control Unit Devices (Product Code ODA)
18 devices
About Product Code ODA - Regulatory Context
510(k) Submission Activity
18 total 510(k) submissions under product code ODA since 1998, with 18 receiving FDA clearance (average review time: 134 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
ODA devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →