510(k) K991266

<GENX> EMBRYO TRANSFER CATHETER CC GLIDER by <Genx> Intl., Inc. — Product Code MQF

K991266 is an FDA 510(k) premarket notification submitted by <Genx> Intl., Inc. for the device "<GENX> EMBRYO TRANSFER CATHETER CC GLIDER". The FDA issued a decision of Substantially Equivalent on September 9, 1999. The device falls under product code MQF (Catheter, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6110. <Genx> Intl., Inc. has at least 10 other 510(k) clearances on record.