510(k) K982867

HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000 by Davol Inc., Sub. C. R. Bard, Inc. — Product Code HIG

K982867 is an FDA 510(k) premarket notification submitted by Davol Inc., Sub. C. R. Bard, Inc. for the device "HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000". The FDA issued a decision of Substantially Equivalent on February 19, 1999. The device falls under product code HIG (Insufflator, Hysteroscopic), a Class II device regulated under 21 CFR 884.1700. Davol Inc., Sub. C. R. Bard, Inc. has at least 10 other 510(k) clearances on record.