BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    PAPCONE

    K Number: K083012 · Decision Apr 9, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    72
    Applicant Total
    1
    Review Days
    182

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    PAPCONE
    K Number
    K083012
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Otto Bock Pur Life Science GmbH
    Date Received
    October 9, 2008
    Decision Date
    April 9, 2009
    Product Code
    HHT
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    HHT Spatula, Cervical, Cytological

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HHT), ordered by most recent decision date.

    exCellerator Cervical Collection Device

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Kolplast Cervical Sample Collection Kit

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DISPOSABLE CERVICAL BRUSH

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    HISTOBRUSH

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SOFTPAP CERVICAL CELL COLLECTOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all