O'NEIL OBSTETRIC CUP

O'NEIL OBSTETRIC CUP is an FDA 510(k)-cleared medical device (K840008) manufactured by Go Medical Industries Pty. , Ltd.. 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 April 24, 1984. Regulation: 8.