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 |
General Surgery Devices
(DHT4A)
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
|
Third Party Review |
Not Third Party Eligible |