BEUDAMED
    Product Code: PLJ FDA class 3 21 CFR 878.4010

    Tissue Adhesive Internal Use

    General, Plastic Surgery

    The Tissue Adhesive Internal Use (product code PLJ) is a Class 3 general and plastic surgery device intended for the fixation of surgical meshes, regulated under 878.4010. Class 3 classification requires Premarket Approval (PMA), reflecting the higher risk profile of internally used adhesive implants. The device is flagged as an implant and is not life-sustaining.

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    510(k)s
    0
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    PLJ
    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
    —
    Summary Malfunction Reporting

    Definition

    Intended for the fixation of surgical meshes.

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.