BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    Apyx

    K Number: K213783 · Decision Apr 5, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    123

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    Basic Information

    Device Name
    Apyx
    K Number
    K213783
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Escala Medical
    Date Received
    December 3, 2021
    Decision Date
    April 5, 2022
    Product Code
    PBQ
    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
    PBQ Fixation, Non-Absorbable Or Absorbable, For Pelvic Use

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    Other Clearances by Escala Medical

    K Number Device Name
    K230730 Apyx