510(k) K911844

HYSTEROFLATOR 1500 by F.M. Wiest USA, Inc. — Product Code HIG

K911844 is an FDA 510(k) premarket notification submitted by F.M. Wiest USA, Inc. for the device "HYSTEROFLATOR 1500". The FDA issued a decision of Substantially Equivalent on November 21, 1991. 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.