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510(k) Data Aggregation

    K Number
    K151095
    Device Name
    Circumplast Circumcision Device
    Manufacturer
    Novadien Healthcare
    Date Cleared
    2015-09-18

    (148 days)

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

    Novadien Healthcare

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Circumplast single use circumcision device is intended to be used to perform circumcisions on infant males. This device consists of two components: Circumplast Circumcision Device and Ligature. The Ligature was tested for use with Circumplast Circumcision Device only.
    Device Description
    The Circumplast is a device composed of two components, a transparent plastic conic tube, and a linen ligature. The device is sold sterile for single use, packaged in a sterile pouch. The Circumplast is available in four (4) sizes, to accommodate size of the infant's penis. The Circumplast is designed to perform a circumferential crushing of the foreskin (prepuce) between the inner ring and outer ring. The inner ring is placed over the penis, at the level of the coronal sulcus. After local anesthesia, the healthcare Practitioner fixes the patient's foreskin over the inner ring and then the prepuce is tied all around, over the groove of the bell, with a tight ligature. Skin forward of the crush line is trimmed away. After the procedure, the Circumplast device remains on the patient for 7 days. The Circumplast falls off after 3 - 7 days.
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