510(k) K071127

FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM by Vision-Sciences, Inc. — Product Code HIH

K071127 is an FDA 510(k) premarket notification submitted by Vision-Sciences, Inc. for the device "FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM". The FDA issued a decision of Substantially Equivalent on November 16, 2007. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Vision-Sciences, Inc. has at least 10 other 510(k) clearances on record.