Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators

Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators is an FDA 510(k)-cleared medical device (K200248) manufactured by Allwin Medical Devices, 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 June 30, 2020. Regulation: 8.