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510(k) Data Aggregation

    K Number
    K153128
    Device Name
    Kolplast Cervical Sample Collection Kit
    Manufacturer
    KOLPLAST CI SA
    Date Cleared
    2017-01-13

    (442 days)

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

    KOLPLAST CI SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kolplast Cervical Sample Collection Kit is intended for collection of cytological specimens from the ectocervix and the endocervix for conventional Pap Smear Test or Liquid-Based ThinPrep® Pap Test with PreservCyt® solution. For prescription use only. It is not intended for use in pregnant women and should be used by a clinical or other qualified health professional only.
    Device Description
    The Kolplast Cervical Sample Collection Kit is composed of the Kolplast Cervical Brush Protected Tip and the Kolplast Cervical Plastic Spatula and is a single use, non-sterile, disposable manual gynecological device. The Cervical Brush Protected Tip is intended for the collection of cytological specimens from the endocervix and the Cervical Plastic Spatula is intended for the collection of cytological specimens from the ectocervix. The Cervical Brush Protected Tip has a head consisting of white nylon bristles, and secured by stainless steel to the plastic handle. During collection of endocervical cells, the Cervical Brush Protected Tip is inserted into the cervix, rotated once via the handle and removed from the cervix. The collected cytological specimen is then transferred to the glass slide by smearing, or to the preservative fluid in a container by rotating the tip 10 times while pushing against the container wall. The Kolplast Plastic Spatula is made of plastic and incorporates a long edge and a notched end. During collection of ectocervical cells, the notched end is put against and rotated 360° around the circumference of the ectocervix. The retained cytological specimen is then transferred to the same glass slide by smearing, or to the preservative fluid in the same container by swirling 10 times. The collected samples on glass slide, or in preservative fluid in a container will be sent to a cytology lab for Pap Test analysis.
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