510(k) K161970

Follicle Aspiration Set by Vitrolife Sweden AB — Product Code MQE

K161970 is an FDA 510(k) premarket notification submitted by Vitrolife Sweden AB for the device "Follicle Aspiration Set". The FDA issued a decision of Substantially Equivalent on June 14, 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.