510(k) K203626

SureStrip Vitrification Straw, SureLock Vitrification Straw by Allwin Medical Devices, Inc. — Product Code MQK

K203626 is an FDA 510(k) premarket notification submitted by Allwin Medical Devices, Inc. for the device "SureStrip Vitrification Straw, SureLock Vitrification Straw". The FDA issued a decision of Substantially Equivalent on June 4, 2021. The device falls under product code MQK (Labware, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6160. Allwin Medical Devices, Inc. has at least 6 other 510(k) clearances on record.