BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    Anscare SIMO Negative Pressure Wound Therapy (NPWT) System

    K Number: K193185 · Decision May 4, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    16
    Applicant Total
    4
    Review Days
    168

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    Basic Information

    Device Name
    Anscare SIMO Negative Pressure Wound Therapy (NPWT) System
    K Number
    K193185
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4683
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Benq Materials Corporation
    Date Received
    November 18, 2019
    Decision Date
    May 4, 2020
    Product Code
    OKO
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OKO Negative Pressure Wound Therapy Non-Powered Suction Apparatus

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