Device |
surgical smoke precipitator |
Regulation Description |
Surgical smoke precipitator. |
Definition |
The device is intended to precipitate surgical smoke to allow surgeons adequately visualize laparoscopic surgeries in the using surgical smoke/aerosolized particulate surgical tools. |
Physical State |
The device consists of an ion delivery system and a power source. |
Technical Method |
The device is introduced into the laparoscopic site and provides the source of the ions that charge the surgical smoke particles and facilitate precipitation of surgical smoke and other aerosolized particulates |
Target Area |
The device is intended for laparoscopic surgery sites. |
Regulation Medical Specialty |
General & Plastic Surgery |
Review Panel |
General Hospital |
Product Code | PQM |
Premarket Review |
Infection Control and Plastic and Reconstructive Surgery Devices
(DHT4B)
Infection Control and Plastic and Reconstructive Surgery Devices
(DHT4B)
|
Submission Type |
510(k)
|
Regulation Number |
878.5050
|
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 |