BEUDAMED
    Product Code: NGR FDA class 2 21 CFR 888.1100

    Tester, Stiffness, Cartilage, Arthroscopic

    Orthopedic

    The Tester, Stiffness, Cartilage, Arthroscopic (product code NGR) is an orthopedic diagnostic device used during arthroscopic surgery to measure the mechanical stiffness of articular cartilage, providing quantitative assessment of cartilage quality to guide surgical decision-making. It is classified as an FDA Class 2 device within the Orthopedic specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.

    View on FDA
    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    2
    Years Active
    0

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    Basic Information

    Product Code
    NGR
    Device Class
    FDA class 2
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K013429 ACTAEON PROBE
    K010303 ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE