510(k) K921871

HYSTEROMAT(TM) 3700 by F.M. Wiest USA, Inc. — Product Code HIG

K921871 is an FDA 510(k) premarket notification submitted by F.M. Wiest USA, Inc. for the device "HYSTEROMAT(TM) 3700". The FDA issued a decision of Substantially Equivalent on December 15, 1994. The device falls under product code HIG (Insufflator, Hysteroscopic), a Class II device regulated under 21 CFR 884.1700. F.M. Wiest USA, Inc. has at least 10 other 510(k) clearances on record.