SAB — Table Mounted Miniaturized Electromechanical Surgical System Class II
FDA product code SAB covers "Table Mounted Miniaturized Electromechanical Surgical System", a Class II medical device regulated under 21 CFR 878.4962. Submissions are reviewed by the General, Plastic Surgery panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SAB
- Device Class
- Class II
- Regulation Number
- 878.4962
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN230025 | virtual incision | MIRA Surgical System | February 23, 2024 |