SonoFlow Sonohysterography and Sonohysterosalpingography Device

SonoFlow Sonohysterography and Sonohysterosalpingography Device is an FDA 510(k)-cleared medical device (K142545) manufactured by Crossbay Medical, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 19, 2015. Regulation: 8.