TRUCLEAR Operative Hysteroscope 5C and Sheath 5C

TRUCLEAR Operative Hysteroscope 5C and Sheath 5C is an FDA 510(k)-cleared medical device (K152143) manufactured by Smith & Nephew, 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 September 1, 2015. Regulation: 8.