K233789 is an FDA 510(k) clearance for the 8Q10 Surclear Smoke Plume Evacuation System. This device is classified as a Apparatus, Exhaust, Surgical (Class II - Special Controls, product code FYD).
Submitted by Surnic Corporation (Brea, US). The FDA issued a Cleared decision on April 10, 2024, 134 days after receiving the submission on November 28, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.5070.
| 510(k) Number | K233789 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 28, 2023 |
| Decision Date | April 10, 2024 |
| Days to Decision | 134 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FYD - Apparatus, Exhaust, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5070 |