BEUDAMED
    Product Code: JXY FDA class 1 21 CFR 874.3540

    Jig, Piston Cutting, Ent, Sterile

    Ear, Nose, Throat

    Jig, Piston Cutting, ENT, Sterile is a sterile surgical accessory that serves as a sizing and cutting guide for piston-type prostheses used in stapedectomy or other middle ear procedures, ensuring accurate length before implantation. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is JXY, regulated under 21 CFR 874.3540, and falls within the Ear, Nose, Throat medical specialty.

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    510(k)s
    0
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    JXY
    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 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.