FDA Product Code DXX: System, Catheter Control, Steerable
Leading manufacturers include Microbot Medical , Ltd. and Stereotaxis, Inc..
FDA 510(k) Cleared System, Catheter Control, Steerable Devices (Product Code DXX)
About Product Code DXX - Regulatory Context
510(k) Submission Activity
33 total 510(k) submissions under product code DXX since 1990, with 33 receiving FDA clearance (average review time: 166 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under DXX have taken an average of 209 days to reach a decision - up from 164 days historically. Manufacturers should account for longer review timelines in current project planning.
DXX devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →