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510(k) Data Aggregation

    K Number
    K062563
    Device Name
    FEMTEN CERVICAL TENACULUM
    Manufacturer
    FEM SUITE, L.L.C.
    Date Cleared
    2007-05-18

    (260 days)

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

    FEM SUITE, L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FemSuite, LLC, FemTen™ Cervical Tenaculum is a sterile, disposable, manual instrument indicated for single patient use to hold and manipulate the cervix. This device is typically used in conjunction with endometrial biopsy.
    Device Description
    Not Found
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