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

    Crystal Vision

    K Number: K163659 · Decision Oct 30, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    74
    Applicant Total
    16
    Review Days
    307

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    Basic Information

    Device Name
    Crystal Vision
    K Number
    K163659
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.5070
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    I.C Medical, Inc.
    Date Received
    December 27, 2016
    Decision Date
    October 30, 2017
    Product Code
    FYD
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FYD Apparatus, Exhaust, Surgical

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    Other Clearances by I.C Medical, Inc.

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    K955020 PENEVAC ABC HANDPIECE
    K953418 ELECTROCAUTERY SHROUD
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    K932230 CRYSTAL VISION AND ACCESSORIES
    K930098 SPECULUM SMOKE EVACUATOR TUBING
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