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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Manipulator/Injector, Uterine
510(k) Number K253403
Device Name FemVue® Controlled Saline-Air Device (FSA-300)
Applicant
Femasys, Inc.
3950 Johns Creek Court Suite 100
Cumming,  GA  30041
Applicant Contact Christine Thomas
Correspondent
Femasys, Inc.
3950 Johns Creek Court Suite 100
Cumming,  GA  30041
Correspondent Contact Christine Thomas
Regulation Number884.4530
Classification Product Code
LKF  
Date Received09/30/2025
Decision Date 12/15/2025
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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