SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)
K-Number: K241348 · 2025-01-31
ApplicantMotilitycount Aps
Decision Date2025-01-31
Product CodeMQK
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) is a medical device manufactured by Motilitycount Aps. It received FDA 510(k) clearance on 2025-01-31 under approval number K241348. The device is classified under product code MQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)?
SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) is a medical device that received FDA 510(k) clearance on 2025-01-31. It is manufactured by Motilitycount Aps. The 510(k) number is K241348.
When was SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) approved by the FDA?
SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) received FDA 510(k) clearance on 2025-01-31, under approval number K241348.
What company makes SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)?
SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) is manufactured by Motilitycount Aps.
What is the FDA product code for SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)?
The FDA product code for SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) is MQK.
Other Devices by Motilitycount Aps
Related Devices (Code: MQK)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.