INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX

INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX is an FDA 510(k)-cleared medical device (K100517) manufactured by Instrumed International, 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 April 28, 2010. Regulation: 8.