510(k) K172050

Follicle Aspiration Set, Reduced Single Lumen by Vitrolife Sweden AB — Product Code MQE

K172050 is an FDA 510(k) premarket notification submitted by Vitrolife Sweden AB for the device "Follicle Aspiration Set, Reduced Single Lumen". The FDA issued a decision of Substantially Equivalent on November 21, 2017. The device falls under product code MQE (Needle, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6100. Vitrolife Sweden AB has at least 10 other 510(k) clearances on record.