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

    ALEXIS LAPAROSCOPIC SYSTEM

    K Number: K093296 · Decision Nov 5, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    8
    Applicant Total
    45
    Review Days
    15

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    Basic Information

    Device Name
    ALEXIS LAPAROSCOPIC SYSTEM
    K Number
    K093296
    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
    Applied Medical Resources Corp.
    Date Received
    October 21, 2009
    Decision Date
    November 5, 2009
    Product Code
    KGW
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    KGW Ring (Wound Protector), Drape Retention, Internal

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KGW), ordered by most recent decision date.

    Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)

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    ALEXIS O WOUND PROTECTOR/RETRACTOR

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    ALEXIS ORTHOPAEDIC WOUND RETRACTOR

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    ALEXIS WOUND RETRACTOR

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    FDA Class 2 ·General, Plastic Surgery

    ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304

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