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

    ENDODRAPE

    K Number: K070406 · Decision Jul 30, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    2
    Review Days
    168

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    Basic Information

    Device Name
    ENDODRAPE
    K Number
    K070406
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vortek Surgical, LLC
    Date Received
    February 12, 2007
    Decision Date
    July 30, 2007
    Product Code
    KKX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    KKX Drape, Surgical, Antimicrobial

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    Other Clearances by Vortek Surgical, LLC

    K Number Device Name
    K080341 ENDODRAPE(TM)