| Device |
electromechanical system for open microsurgery |
| Definition |
An electromechanical system for open microsurgery is a software-controlled electromechanical system with bedside human/device interfaces and without an integrated visualization system which allows a qualified user to perform surgical techniques during open mircosurgical procedures using surgical instruments attached to an electromechanical arm. |
| Physical State |
The device may contain a bedside control console, robotic arms, and associated accessories. |
| Technical Method |
The device utilizes two electromechanical arms with instruments that are controlled by a qualified surgeon to manipulate small structures. The device utilizes a 3rd party microscope to visualize the anatomy. |
| Target Area |
head, neck, breast, trunk, upper limbs, and lower limbs |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | SAQ |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
General Surgery Devices
(DHT4A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.4963
|
|---|
| 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 |
