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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Reproductive
510(k) Number K242640
Device Name FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin
Applicant
Fertipro NV
Industriepark Noord 32
Beernem,  BE 8730
Applicant Contact Liesbeth Faes
Correspondent
Rock Quality Systems
1155 Mount Vernon Hwy., Suite 800
Dunwoody,  GA  30338
Correspondent Contact Sarah Robbins
Regulation Number884.6180
Classification Product Code
MQL  
Date Received09/03/2024
Decision Date 05/30/2025
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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