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510(k) Data Aggregation

    K Number
    K122658
    Device Name
    FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009
    Manufacturer
    FEMASYS INC.
    Date Cleared
    2012-12-20

    (111 days)

    Product Code
    PCF
    Regulation Number
    884.1050
    Why did this record match?
    Product Code :

    PCF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Femasys FemCerv is a sterile, disposable endocervical sampler indicated for single patient use in obtaining tissue samples from the endocervical canal for histological analysis. Clinical indications include: further evaluation of an abnormal Pap smear; cervical lesions extending into the endocervical canal; undiagnosed uterine bleeding.
    Device Description
    The FemCerv Endocervical Sampler (FemCerv) is a sterile, disposable device that collects an endocervical tissue sample for histological evaluation.
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    K Number
    K060320
    Device Name
    FEMECC ENDOCERVICAL CURETTE
    Manufacturer
    FEMSPEC L.L.C.
    Date Cleared
    2006-07-28

    (170 days)

    Product Code
    PCF
    Regulation Number
    884.1050
    Why did this record match?
    Product Code :

    PCF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FemSpec, LLC, FemECC™ Endocervical Curette is a sterile, disposable curette indicated for single patient use in obtaining tissue samples from the endocervical canal for histological analysis.
    Device Description
    FemSpec, LLC, FemECC™ Endocervical Curette is a sterile, disposable curette.
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