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 2 recent 510(k) clearances have 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