IMAGYN HYSTEROSCOPE

IMAGYN HYSTEROSCOPE is an FDA 510(k)-cleared medical device (K952033) manufactured by Imagyn 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 July 23, 1995. Regulation: 8.