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

    ALEXIS WOUND RETRACTOR

    K Number: K062907 · Decision Jan 9, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    8
    Applicant Total
    58
    Review Days
    104

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    Basic Information

    Device Name
    ALEXIS WOUND RETRACTOR
    K Number
    K062907
    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
    Date Received
    September 27, 2006
    Decision Date
    January 9, 2007
    Product Code
    KGW
    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
    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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    FDA Class 2 ·General, Plastic Surgery

    ALEXIS O WOUND PROTECTOR/RETRACTOR

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    FDA Class 2 ·General, Plastic Surgery

    ALEXIS ORTHOPAEDIC WOUND RETRACTOR

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    FDA Class 2 ·General, Plastic Surgery

    ALEXIS LAPAROSCOPIC SYSTEM

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

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

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