SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE

SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE is an FDA 510(k)-cleared medical device (K133144) 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 18, 2014. Regulation: 8.