PQM
7 FDA 510(k) clearances · Product code
136 daysmedian time to decision
574 days90th percentile
7clearances measured
FDA profile
- Official device name
- Surgical Smoke Precipitator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5050
- Medical specialty
- General, Plastic Surgery
- FDA definition
- The device is intended to precipitate surgical smoke to allow surgeons adequately visualize laparoscopic surgeries in the using surgical smoke/aerosolized particulate surgical tools.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Ultravision2™ IonPencil (K240868) | Alesi Surgical Limited | 2024-08-12 |
| Ultravision2™ System Integrated Monopolar L-Hook (H/S)™ (K231298) | Alesi Surgical, Ltd. | 2023-10-31 |
| Ultravision2™ System (K231238) | Alesi Surgical, Ltd. | 2023-10-31 |
| Ultravision Visual Field Clearing System (K200035) | Alesi Surgical, Ltd. | 2020-05-04 |
| Ultravision™ Visual Field Clearing System (K182053) | Alesi Surgical, Ltd. | 2018-09-07 |
| Ultravision Visual Field Clearing System (K170178) | Alesi Surgical, Ltd. | 2017-05-26 |
| Ultravision Visual Clearing System (DEN150022) | Alesi Surgical, Ltd. | 2016-12-20 |
Track PQM automatically
Every clearance here is in the API, with alerts when new ones post.