510(k) K233789

8Q10 Surclear Smoke Plume Evacuation System by Surnic Corporation — Product Code FYD

K233789 is an FDA 510(k) premarket notification submitted by Surnic Corporation for the device "8Q10 Surclear Smoke Plume Evacuation System". The FDA issued a decision of Substantially Equivalent on April 10, 2024. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. Surnic Corporation has at least 1 other 510(k) clearance on record.