510(k) K240127

PlumeSafe X5 Smoke Management System by Conmed Corporation — Product Code FYD

K240127 is an FDA 510(k) premarket notification submitted by Conmed Corporation for the device "PlumeSafe X5 Smoke Management System". The FDA issued a decision of Substantially Equivalent on August 5, 2024. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. Conmed Corporation has at least 10 other 510(k) clearances on record.