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510(k) Data Aggregation

    K Number
    K073576
    Device Name
    NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES
    Manufacturer
    HAROD ENTERPRISES, INC.
    Date Cleared
    2008-02-22

    (65 days)

    Product Code
    HBA
    Regulation Number
    882.4700
    Why did this record match?
    Applicant Name (Manufacturer) :

    HAROD ENTERPRISES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The neurological sponge is a cotton or rayon pattie used to keep exposed tissue from drying out during surgery. It is used to absorb excess fluids and to protect the tissue from trauma during surgery. It is also used to assist in the gentle suction of fluids.
    Device Description
    Neurosurgical Paddies are used to keep exposed tissue from drying out or to absorb excess fluids and to protect the tissue from trauma during surgery. They are manufactured from either cotton or viscose fibers cut into rectangular pads of various sizes with a suture string attached for ease in count verification and with an x-ray detectable marker sewn to it as an extra precaution. The paddies are normally packaged 10 per count card of a single size and may be sterilized for end use or sold non sterile for kit packers. They are single use items that can be ETO sterilized twice or E-beam sterilized once. HE, Inc.'s product will be made from cotton and/or or rayon in sizes and shapes similar to the predicate devices as they have been since 2005 under a 510(k) license. The most commonly used sizes are ½' x ½', ½' x 1", ½" x 3", 1" x 1" and 1" x 3".
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