FDA Product Code SAB: Table Mounted Miniaturized Electromechanical Surgical System
A Table Mounted Miniaturized Electromechanical Surgical System Is A Software-controlled Electromechanical System With Surgical Table Mounted Patient/device Interfaces Which Allows A Qualified User To Perform Surgical Techniques During Minimally Invasive Surgical Procedures Where The Software-controlled Electromechanical Devices Miniaturized And Compact Size Allows The Effective Element Of The System To Be Inserted Into The Body Cavity And Use Surgical Instruments Attached To The Electromechanical Arms
Leading manufacturers include Virtual Incision.
FDA 510(k) Cleared Table Mounted Miniaturized Electromechanical Surgical System Devices (Product Code SAB)
About Product Code SAB - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SAB since 2024, with 0 receiving FDA clearance (average review time: 318 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
SAB devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →