510(k) K233177

Nest VT Vitrification Device by Cook Incorporated — Product Code MQK

K233177 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Nest VT Vitrification Device". The FDA issued a decision of Substantially Equivalent on March 8, 2024. The device falls under product code MQK (Labware, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6160. Cook Incorporated has at least 10 other 510(k) clearances on record.