510(k) K242640

FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin by Fertipro NV — Product Code MQL

K242640 is an FDA 510(k) premarket notification submitted by Fertipro NV for the device "FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin". The FDA issued a decision of Substantially Equivalent on May 30, 2025. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Fertipro NV has at least 3 other 510(k) clearances on record.