BEUDAMED
    Product Code: LRE FDA class 1 21 CFR 874.3540

    Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Sterile

    Ear, Nose, Throat

    This sterile instrument is used to modify prosthetic components during ossicular replacement surgery, a procedure in which damaged middle ear ossicles are replaced with prosthetic devices to restore sound transmission and improve hearing. It is classified as a Class 1 (lowest risk) device, subject only to general controls, representing the least burdensome regulatory category. The product code is LRE, regulated under 21 CFR 874.3540, within the Ear, Nose, and Throat medical specialty. No special flags apply to this device.

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    510(k)s
    0
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    LRE
    Device Class
    FDA class 1
    Regulation Number
    874.3540
    Medical Specialty
    Ear, Nose, Throat
    Review Panel
    EN
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.