BEUDAMED
    Product Code: MAW FDA class 1 21 CFR 878.4800

    Marker, Suture Identification

    General, Plastic Surgery

    The suture identification marker is a general surgery device used to label or distinguish suture materials during surgical procedures, aiding in identification and tracking of suture types or placement sites. It is classified as FDA Class I under 21 CFR 878.4800 within the General and Plastic Surgery specialty, subject only to general controls. The product code is MAW and the device is not GMP-exempt, requiring basic quality system compliance. It is not implanted and does not sustain life.

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    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    MAW
    Device Class
    FDA class 1
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K896472 KEY VASCULAR BOOTIES