About This 510(k) Submission
K151018 is an FDA 510(k) clearance for the Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette, a Microtools, Assisted Reproduction (pipettes) (Class II — Special Controls, product code MQH), submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on January 8, 2016, 267 days after receiving the submission on April 16, 2015. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6130.