| Device |
mountable electromechanical surgical system for transluminal approaches |
| Regulation Description |
Mountable electromechanical surgical system for transluminal approaches. |
| Definition |
A mountable electromechanical surgical system for transluminal approaches is a software-controlled, patient bed- and/or operating table-mounted electromechanical surgical system with human/device interfaces that allows a qualified user to perform transluminal endoscopic or laparoscopic surgical procedures using surgical instruments attached to an electromechanical arm. |
| Physical State |
The device may contain control console, surgical arms, motor units, and a trocar kit, with associated accessories. |
| Technical Method |
The device utilizes two electromechanical arms that are controlled by a qualified surgeon to manipulate the tissue and, with the aid of an electrosurgical generator, deliver monopolar and bipolar energy to perform the intended surgical procedures. The device utilizes a 3rd party laparoscope to gain visualization of the anatomical space and a proprietary trocar kit to obtain transvaginal access. |
| Target Area |
Human body excluding orthopedic applications. |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | QNM |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
General Surgery Devices
(DHT4A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.4961
|
|---|
| 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
|
|---|
| Recognized Consensus Standard
|
| Third Party Review |
Not Third Party Eligible |
