510(k) K202862

Gx-IVF, Gx-TL, Gx-MOPS PLUS by Vitrolife Sweden AB — Product Code MQL

K202862 is an FDA 510(k) premarket notification submitted by Vitrolife Sweden AB for the device "Gx-IVF, Gx-TL, Gx-MOPS PLUS". The FDA issued a decision of Substantially Equivalent on May 14, 2021. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Vitrolife Sweden AB has at least 10 other 510(k) clearances on record.