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.
2
Total
1
Cleared
239d
Avg days
2024
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg
160d
recently vs 318d historically
FDA 510(k) Cleared Table Mounted Miniaturized Electromechanical Surgical System Devices (Product Code SAB)
2 devices
Cleared
Aug 20, 2026
MIRA Surgical System
Virtual Incision
General & Plastic Surgery
160d
Not Cleared
Feb 23, 2024
MIRA Surgical System
Virtual Incision
General & Plastic Surgery
318d
About Product Code SAB - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code SAB since 2024, with 1 receiving FDA clearance (average review time: 239 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - SAB Product Code
Recent submissions under SAB have taken an average of 160 days to reach a decision - down from 318 days historically, suggesting improved FDA processing for this classification.
SAB devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →