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    Aquilex Fluid Control System AQL-100S

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Manipulat 3 F-EL

    Device
    EU MDR · Eu Md Class 1 ·BEKA-Hospitec GmbH·On the market·32 countries

    Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Models AQL-100PBS and AQL-100P

    FDA Enforcement
    Class II ·Ongoing·WOM World Of Medicine AG·October 4, 2023

    Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.

    FDA Enforcement
    Class II ·Terminated·WOM World of Medicine AG·October 9, 2019