| Device |
integrated operating table-electromechanical surgical system |
| Definition |
An integrated operating table-electromechanical surgical system is a software-controlled electromechanical platform, consisting of a surgical table with integrated robotic arms and table motion capability, that enables a qualified user to perform surgical techniques during minimally invasive and laparoscopic surgical procedures. The surgical table can be used for open surgical procedures independent of the robotic platform. |
| Physical State |
The device may contain operating table with integrated robotic arms, operator console, operating room (OR) staff subassembly, and associated instruments and accessories. |
| Technical Method |
The device utilizes multiple electromechanical arms with surgical instruments that are controlled by a qualified user through the operator console to manipulate structures in the human body. The table can be adjusted without undocking the patient. |
| Target Area |
abdomen, torso |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | SIR |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
General Surgery Devices
(DHT4A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.4966
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
