BEUDAMED
    Product Code: QQS FDA class 1 21 CFR 878.4740

    Stapler, Skin

    General Hospital

    The Skin Stapler is a Class 1 prescription surgical device used to deliver compatible staples to skin during surgery, serving as a specialized wound closure tool for external use in surgical settings. It is subject to general controls under regulation 878.4740 in the General Hospital specialty (reviewed by the General and Plastic Surgery panel). Product code QQS. The device is not an implant and is not life-sustaining.

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    510(k)s
    0
    FEI Numbers
    52
    Registration Numbers
    52
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    QQS
    Device Class
    FDA class 1
    Regulation Number
    878.4740
    Medical Specialty
    General Hospital
    Review Panel
    SU
    Submission Type
    4

    Device Characteristics

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

    Definition

    A surgical stapler for external use is a specialized prescription device used to deliver compatible staples to skin during surgery.

    FEI Numbers

    This FDA classification entry is associated with 52 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 52 registration numbers. Click on an entry to view related FDA registrations.