Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K182049
    Device Name
    exCellerator Cervical Collection Device
    Manufacturer
    ExCell Company LLC
    Date Cleared
    2019-04-25

    (268 days)

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

    ExCell Company LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ExCellerator Cervical Collection Device is a cervical spatula intended for collecting ectocervical specimens for the ThinPrep Pap test. The device is also intended to be used to aid in a more complete transfer of the specimen material from the endocervical brush (cytobrush) to the PreservCyt solution for ThinPrep testing. The ExCellerator device must be used with an IVD labeled endocervical brush.
    Device Description
    The ExCellerator™ Cervical Collection Device is a non-sterile, single use, disposable cervical sampling device (spatula), comprised of inert food grade polypropylene plastic, intended for sampling the ectocervix during the cervical sample collection procedure. Additionally, it aids in more complete transfer of the cytological sample collected with an IVD labeled endocervical brush (cytobrush) into the PreservCyt vial for the preparation of ThinPrep Pap test slides.
    Ask a Question

    Page 1 of 1