510(k) K842943

AXCAN UTERINE SUCCION INJECTOR by Axcan Scientific Corp. — Product Code HIG

K842943 is an FDA 510(k) premarket notification submitted by Axcan Scientific Corp. for the device "AXCAN UTERINE SUCCION INJECTOR". The FDA issued a decision of Substantially Equivalent on September 21, 1984. The device falls under product code HIG (Insufflator, Hysteroscopic), a Class II device regulated under 21 CFR 884.1700. Axcan Scientific Corp. has at least 4 other 510(k) clearances on record.