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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Labware, Assisted Reproduction
510(k) Number K232980
Device Name SpermAlign Sperm Separation Device
Applicant
Cytoswim, Ltd.
Unit 34, The Venture Centre,
University Of Warwick Science Park,
Coventry,  GB CV4 7EZ
Applicant Contact Max Meissner
Correspondent
Insight Regulatory Consultancy , Ltd.
Unit A, Wixford Park, Georges Elm Ln.
Alcester,  GB B50 4JS
Correspondent Contact Zennia Paniwnyk
Regulation Number884.6160
Classification Product Code
MQK  
Date Received09/21/2023
Decision Date 03/14/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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