BEUDAMED
    Product Code: SFG FDA class 1 21 CFR 878.4160

    Camera, Surgical, Measurement

    General, Plastic Surgery
    View on FDA
    510(k)s
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    SFG
    Device Class
    FDA class 1
    Regulation Number
    878.4160
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    4

    Device Characteristics

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

    Definition

    An adjunctive tool to measure and record a body part’s physical data, such as diameter, surface area, volume, and perimeter/circumference. The device does not provide a diagnosis or therapy.

    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
    K251255 LymphaTech Mobile 3D Measuring Tool

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.