BEUDAMED
    Product Code: PJK FDA class 3 21 CFR 878.4010

    Tissue Adhesive For Internal Use

    General, Plastic Surgery

    The Tissue Adhesive for Internal Use is a surgical adhesive device indicated for the approximation of tissue layers where subcutaneous dead space exists between tissue planes, such as in abdominoplasty procedures. It is an FDA Class 3 device regulated under 21 CFR 878.4010, requiring Pre-Market Approval (PMA), within the General and Plastic Surgery (SU) specialty. The product code is PJK, and it is flagged as an implant given its internal tissue application. This device is not life-sustaining.

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    Basic Information

    Product Code
    PJK
    Device Class
    FDA class 3
    Regulation Number
    878.4010
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
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    Summary Malfunction Reporting

    Definition

    Approximation of tissue layers where subcutaneous dead space exists between the tissue planes in abdominoplasty.