510(k) K191291

Wallace Dual Lumen Oocyte Recovery System by CooperSurgical, Inc. — Product Code MQE

K191291 is an FDA 510(k) premarket notification submitted by CooperSurgical, Inc. for the device "Wallace Dual Lumen Oocyte Recovery System". The FDA issued a decision of Substantially Equivalent on June 12, 2019. The device falls under product code MQE (Needle, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6100. CooperSurgical, Inc. has at least 10 other 510(k) clearances on record.