BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    POWERSEAL Curved Jaw Sealer and Divider, Double Action

    K Number: K212643 · Decision Sep 27, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    12
    Review Days
    38

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    Basic Information

    Device Name
    POWERSEAL Curved Jaw Sealer and Divider, Double Action
    K Number
    K212643
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Olympus Surgical Technologies America
    Date Received
    August 20, 2021
    Decision Date
    September 27, 2021
    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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