BEUDAMED
    Product Code: JYQ FDA class 1 21 CFR 874.4420

    Loop, Wire

    Ear, Nose, Throat

    Loop, Wire is a fine wire instrument used in ENT microsurgery to manipulate, position, or remove small structures or foreign material within the ear canal or middle ear, including use in stapedectomy for shaping or positioning prosthetic elements. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is JYQ, regulated under 21 CFR 874.4420, and falls within the Ear, Nose, Throat medical specialty.

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    510(k)s
    2
    FEI Numbers
    87
    Registration Numbers
    87
    Unique Applicants
    2
    Years Active
    2

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    Basic Information

    Product Code
    JYQ
    Device Class
    FDA class 1
    Regulation Number
    874.4420
    Medical Specialty
    Ear, Nose, Throat
    Review Panel
    EN
    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
    K890221 MICROSURGICAL WIRE LOOP
    K870761 EAR LOOP

    FEI Numbers

    This FDA classification entry is associated with 87 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 87 registration numbers. Click on an entry to view related FDA registrations.