510(k) K991264

<GENX> SINGLE LUMEN SIDEPORT NEEDLE by <Genx> Intl., Inc. — Product Code MQE

K991264 is an FDA 510(k) premarket notification submitted by <Genx> Intl., Inc. for the device "<GENX> SINGLE LUMEN SIDEPORT NEEDLE". The FDA issued a decision of Substantially Equivalent on September 9, 1999. The device falls under product code MQE (Needle, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6100. <Genx> Intl., Inc. has at least 10 other 510(k) clearances on record.