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Surgical Smoke Precipitator

FDA product code PQM · 6 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.5050
Review panel
HO
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2017-05-26 – 2024-08-12

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

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