PQM · Class II · 21 CFR 878.5050

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.

7
Total
6
Cleared
194d
Avg days
2016
Since
Declining activity - 0 submissions in the last 2 years vs 3 in the prior period

FDA 510(k) Cleared Surgical Smoke Precipitator Devices (Product Code PQM)

7 devices
1–7 of 7
Cleared Aug 12, 2024
Ultravision2™ IonPencil
K240868
Alesi Surgical Limited
General Hospital · 136d
Cleared Oct 31, 2023
Ultravision2™ System
K231238
Alesi Surgical, Ltd.
General Hospital · 186d
Cleared Oct 31, 2023
Ultravision2™ System Integrated Monopolar L-Hook (H/S)™
K231298
Alesi Surgical, Ltd.
General Hospital · 180d
Cleared May 04, 2020
Ultravision Visual Field Clearing System
K200035
Alesi Surgical, Ltd.
General Hospital · 117d
Cleared Sep 07, 2018
Ultravision™ Visual Field Clearing System
K182053
Alesi Surgical, Ltd.
General Hospital · 38d

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 - 0 submissions in the last 24 months compared to 3 in the prior period.