BEUDAMED
    Product Code: NNQ FDA class 1 21 CFR 874.3540

    Forceps, Wire Closure, Ent, Non-Sterile

    Ear, Nose, Throat

    The ENT wire closure forceps (non-sterile) is a prosthesis modification instrument used in ossicular replacement surgery to close and secure wire loops or components of middle ear prostheses. It is classified as FDA Class 1 under regulation 874.3540 in the Ear, Nose, and Throat specialty, and it is GMP exempt. Product code NNQ does not require a 510(k) submission and is associated with product code JXX.

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    510(k)s
    0
    FEI Numbers
    14
    Registration Numbers
    14
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    NNQ
    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

    Definition

    Prosthesis modification instrument for ossicular replacement surgery; see product code JXX.

    FEI Numbers

    This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.