510(k) K151018

Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette by Cook Incorporated — Product Code MQH

K151018 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette". The FDA issued a decision of Substantially Equivalent on January 8, 2016. The device falls under product code MQH (Microtools, Assisted Reproduction (Pipettes)), a Class II device regulated under 21 CFR 884.6130. Cook Incorporated has at least 10 other 510(k) clearances on record.