SAB
- Product code
- SAB
- Device name
- Table Mounted Miniaturized Electromechanical Surgical System
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4962
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 2
FDA classification definition
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
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260817 | 2026-08-20 | Virtual Incision | MIRA Surgical System | |
| DEN230025 | 2024-02-23 | Virtual Incision | MIRA Surgical System | — |
Official FDA classification page: SAB
Classification and pathway per current FDA publications. Data from openFDA (CC0).