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

    PENEVAC SI.

    K Number: K955166 · Decision Apr 11, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    16
    Review Days
    150

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    Basic Information

    Device Name
    PENEVAC SI.
    K Number
    K955166
    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
    I.C Medical, Inc.
    Date Received
    November 13, 1995
    Decision Date
    April 11, 1996
    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 I.C Medical, Inc.

    K Number Device Name
    K163659 Crystal Vision
    K160160 Non-Telescopic PenEvac
    K003840 CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES
    K960492 SI CONTROLLER MODEL SI 500
    K961616 TELESCOPING PENEVAC (MODIFICATION)
    K955020 PENEVAC ABC HANDPIECE
    K953418 ELECTROCAUTERY SHROUD
    K954088 TELESCOPING PENEVAC
    K932230 CRYSTAL VISION AND ACCESSORIES
    K930098 SPECULUM SMOKE EVACUATOR TUBING
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