510(k) K153267

ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash by Origio A/S — Product Code MQL

K153267 is an FDA 510(k) premarket notification submitted by Origio A/S for the device "ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash". The FDA issued a decision of Substantially Equivalent on Jul 22, 2016. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Origio A/S has 14 other 510(k) clearances on record.