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510(k) Data Aggregation

    K Number
    K061387
    Device Name
    VERESURE BELL
    Manufacturer
    VERESURE, INC.
    Date Cleared
    2006-07-21

    (64 days)

    Product Code
    HIF
    Regulation Number
    884.1730
    Why did this record match?
    Applicant Name (Manufacturer) :

    VERESURE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VereSure Bell is intended for use in the peri-umbilical region of the abdominal wall with a Veress needle for the establishment of pneumoperitoneum during gynecologic laparoscopic procedures.
    Device Description
    The VereSure Bell is a single-use device used during gynecologic laparoscopic surgical procedures. The device consists of a bell-shaped polycarbonate housing containing a sealable port for introduction of standard Veress needles and a stopcock for attachment to a sterile standard hospital vacuum line.
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