510(k) K173731

SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031) by CooperSurgical, Inc. — Product Code MQL

K173731 is an FDA 510(k) premarket notification submitted by CooperSurgical, Inc. for the device "SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031)". The FDA issued a decision of Substantially Equivalent on March 2, 2018. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. CooperSurgical, Inc. has at least 10 other 510(k) clearances on record.