510(k) K181469

Cryotop®US-flash and Cryotop®US-scoop by Kitazato Corporation — Product Code MQK

K181469 is an FDA 510(k) premarket notification submitted by Kitazato Corporation for the device "Cryotop®US-flash and Cryotop®US-scoop". The FDA issued a decision of Substantially Equivalent on November 9, 2018. The device falls under product code MQK (Labware, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6160. Kitazato Corporation has at least 10 other 510(k) clearances on record.