510(k) K241348

SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) by Motilitycount Aps — Product Code MQK

K241348 is an FDA 510(k) premarket notification submitted by Motilitycount Aps for the device "SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)". The FDA issued a decision of Substantially Equivalent on January 31, 2025. The device falls under product code MQK (Labware, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6160. Motilitycount Aps has at least 1 other 510(k) clearance on record.