510(k) K200250

Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor by Megadyne Medical Products, Inc. — Product Code FYD

K200250 is an FDA 510(k) premarket notification submitted by Megadyne Medical Products, Inc. for the device "Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor". The FDA issued a decision of Substantially Equivalent on June 26, 2020. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. Megadyne Medical Products, Inc. has at least 10 other 510(k) clearances on record.