DEN150022 is an FDA 510(k) submission for the Ultravision Visual Clearing System. This device is classified as a Surgical Smoke Precipitator (Class II - Special Controls, product code PQM).
Submitted by Alesi Surgical, Ltd. (Caediff, GB). The FDA issued a Not Cleared (DENG) decision on December 20, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.5050. The Device Is Intended To Precipitate Surgical Smoke To Allow Surgeons Adequately Visualize Laparoscopic Surgeries In The Using Surgical Smoke/aerosolized Particulate Surgical Tools..
| 510(k) Number | DEN150022 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | May 26, 2015 |
| Decision Date | December 20, 2016 |
| Days to Decision | 574 days |
| Submission Type | Direct |
| Review Panel | General Hospital (HO) |
| Summary | - |
| Product Code | PQM - Surgical Smoke Precipitator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5050 |
| 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. |