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

    ShinEvac Smoke Evacuation Pencil

    K Number: K213317 · Decision Jan 28, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    4
    Review Days
    116

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    Basic Information

    Device Name
    ShinEvac Smoke Evacuation Pencil
    K Number
    K213317
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shining World Health Care Co., Ltd.
    Date Received
    October 4, 2021
    Decision Date
    January 28, 2022
    Product Code
    GEI
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by Shining World Health Care Co., Ltd.

    K Number Device Name
    K031370 SHINMED MODE SW-988 UNTRASONIC NEBULIZER
    K033027 SHINMED VARIOUS MODELS OF ELECTRO-SURGICAL PENCILS, SW12200, SW12202, SW12300
    K980024 SHINMED MODEL SW-966 ULTRASONIC NEBULIZER