Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor

About This 510(k) Submission

K200250 is an FDA 510(k) clearance for the Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor, a Apparatus, Exhaust, Surgical (Class II — Special Controls, product code FYD), submitted by Megadyne Medical Products, Inc. (Draper, US). The FDA issued a Cleared decision on June 26, 2020, 144 days after receiving the submission on February 3, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.5070.