| Device |
electromechanical surgical system for endoluminal surgical procedures |
| Definition |
An electromechanical surgical system for endoluminal surgical procedures is a software-controlled electromechanical system with human/device interfaces that allows a qualified user to perform surgical procedures using robotically-controlled instruments passed through an endoscope into a body lumen. |
| Physical State |
The device may contain a surgeon workstation (Console), cart with holding arm, endoscopy equipment, and associated instruments and accessories. |
| Technical Method |
An electromechanical surgical system for endoluminal surgical procedures is a digital electromechanical surgical device that delivers dexterous surgical instruments through an endoscope to perform endoluminal surgical procedures. The surgeon controls the instruments through surgeon input devices at a workstation, which sends commands to motors that move the instruments accordingly at the surgical site. |
| Target Area |
Hollow organs |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | SJS |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
General Surgery Devices
(DHT4A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.4967
|
|---|
| 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 |
