Symphion Endoscope and Symphion Cervical Sheath

Symphion Endoscope and Symphion Cervical Sheath is an FDA 510(k)-cleared medical device (K160751) manufactured by Boston Scientific. 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 June 13, 2016. Regulation: 8.