Surgical Smoke Precipitator

What Is It?

The device is intended to precipitate surgical smoke to allow surgeons adequately visualize laparoscopic surgeries in the using surgical smoke/aerosolized particulate surgical tools.

What Is FDA Product Code PQM?

Surgical Smoke Precipitator is FDA product code PQM, Class 2, 21 CFR 878.5050.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.