BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    ACCELLON CERVICAL BIOSAMPLER

    K Number: K911432 · Decision Sep 3, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    72
    Applicant Total
    2
    Review Days
    885

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    Basic Information

    Device Name
    ACCELLON CERVICAL BIOSAMPLER
    K Number
    K911432
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Medscand AB
    Date Received
    April 2, 1991
    Decision Date
    September 3, 1993
    Product Code
    HHT
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HHT Spatula, Cervical, Cytological

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    Other Clearances by Medscand AB

    K Number Device Name
    K984211 MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303