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510(k) Data Aggregation

    K Number
    K142163
    Device Name
    MALE CIRCUMCISION KITS:RAPIDECLAMP
    Manufacturer
    MEDICFIT TECHNOLOGY SDN BHD
    Date Cleared
    2015-04-20

    (257 days)

    Product Code
    HFX
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICFIT TECHNOLOGY SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Circumcision of foreskin of males from infant to adult by circumferential excision of the foreskin or prepuce at or near the level of coronal sulcus, with minimal amount of preputial skin remaining.
    Device Description
    The Male Circumcision Kits: RAPIDECLAMP™ is a surgical procedure purposely for circumcision which using a set of clamps that involves partial or complete removal of the foreskin (prepuce) of the penis. This device was designed technologically using molding process to replace the conventional method. It was designed specifically to promote faster circumcision process, prevent severe bleeding with less pain. It contains a set of clamp with a protective shield, RAPIDECLAMP™ measuring plate, and a blade or scissor. This device known as RAPIDECLAMP™ is made up of Polycarbonate (PC) and Acrylonitrile butadiene styrene (ABS). Generally, RAPIDECLAMP™ consists of Guide Ring, Spike Body-Front and Rear, Anti-Slip Ring, Locking Cover, and Protective Shield.
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