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
Cleared
Aug 12, 2024
Ultravision2™ IonPencil
Alesi Surgical Limited
General Hospital
136d
Cleared
Oct 31, 2023
Ultravision2™ System
Alesi Surgical, Ltd.
General Hospital
186d
Cleared
Oct 31, 2023
Ultravision2™ System Integrated Monopolar L-Hook (H/S)™
Alesi Surgical, Ltd.
General Hospital
180d
Cleared
May 04, 2020
Ultravision Visual Field Clearing System
Alesi Surgical, Ltd.
General Hospital
117d
Cleared
Sep 07, 2018
Ultravision™ Visual Field Clearing System
Alesi Surgical, Ltd.
General Hospital
38d
Cleared
May 26, 2017
Ultravision Visual Field Clearing System
Alesi Surgical, Ltd.
General Hospital
127d
Not Cleared
Dec 20, 2016
Ultravision Visual Clearing System
Alesi Surgical, Ltd.
General Hospital
574d
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.