About This 510(k) Submission
K173731 is an FDA 510(k) clearance for the SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031), a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by CooperSurgical, Inc. (Trumbull, US). The FDA issued a Cleared decision on March 2, 2018, 86 days after receiving the submission on December 6, 2017. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.