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

    Exofin Fusion Skin Closure System

    K Number: K191461 · Decision Jun 5, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    8
    Applicant Total
    6
    Review Days
    368

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    Basic Information

    Device Name
    Exofin Fusion Skin Closure System
    K Number
    K191461
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4011
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chemence Medical, Inc.
    Date Received
    June 3, 2019
    Decision Date
    June 5, 2020
    Product Code
    OMD
    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
    OMD Cutaneous Tissue Adhesive With Mesh

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    Other Clearances by Chemence Medical, Inc.

    K Number Device Name
    K212246 Exofin Precision Pen
    K200264 Exofin High Viscosity Topical Skin Adhesive
    K171442 Exofin Fusion Skin Closure System
    K162352 derma+flex QS High Viscosity Tissue Adhesive
    K050757 FLEX-AID LIQUID GEL BANDAGE AND DERMAFLEX GEL TISSUE ADHESIVE PROFESSIONAL LIQUID BANDAGE