FDA Product Code PQM: Surgical Smoke Precipitator
The Device Is Intended To Precipitate Surgical Smoke To Allow Surgeons Adequately Visualize Laparoscopic Surgeries In The Using Surgical Smoke/aerosolized Particulate Surgical Tools.
Leading manufacturers include Alesi Surgical, Ltd. and Alesi Surgical Limited.
FDA 510(k) Cleared Surgical Smoke Precipitator Devices (Product Code PQM)
About Product Code PQM - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code PQM since 2016, with 6 receiving FDA clearance (average review time: 194 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA Review Time
Recent submissions under PQM have taken an average of 136 days to reach a decision - down from 204 days historically, suggesting improved FDA processing for this classification.
PQM devices are reviewed by the General Hospital panel. Browse all General Hospital devices →