Product code PQM

Device name

Surgical Smoke Precipitator

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.5050

Review panel

HO

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset