K200035 is an FDA 510(k) clearance for the Ultravision Visual Field Clearing System. This device is classified as a Surgical Smoke Precipitator (Class II - Special Controls, product code PQM).
Submitted by Alesi Surgical, Ltd. (Cardiff, GB). The FDA issued a Cleared decision on May 4, 2020, 117 days after receiving the submission on January 8, 2020.
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 | K200035 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 08, 2020 |
| Decision Date | May 04, 2020 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| 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. |