About This 510(k) Submission
K173871 is an FDA 510(k) clearance for the CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres, a Agents, Embolic, For Treatment Of Uterine Fibroids (Class II — Special Controls, product code NAJ), submitted by Suzhou Hengrui Callisyn Biomedical Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on September 17, 2018, 271 days after receiving the submission on December 20, 2017. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 870.3300.