BEUDAMED
    Product Code: NBH FDA class 1 21 CFR 888.1100

    Accessories, Arthroscopic

    Orthopedic

    Arthroscopic Accessories are orthopedic surgical instruments and accessories used in conjunction with arthroscopic systems during minimally invasive joint surgery, including probes, graspers, punches, shavers, and other ancillary tools used to examine and treat joint pathology. Classified as FDA Class 1, they are subject to general controls under regulation 888.1100 (Orthopedic specialty). These low-risk accessories require only general controls.

    View on FDA
    510(k)s
    2
    FEI Numbers
    298
    Registration Numbers
    298
    Unique Applicants
    2
    Years Active
    0

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    Basic Information

    Product Code
    NBH
    Device Class
    FDA class 1
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    4

    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
    K822560 IRRIGATION SET
    K822109 SHOVEL RETRACTOR

    FEI Numbers

    This FDA classification entry is associated with 298 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 298 registration numbers. Click on an entry to view related FDA registrations.