Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths

Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths is an FDA 510(k)-cleared medical device (K182006) manufactured by Hologic, 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 December 5, 2018. Regulation: 8.