BEUDAMED
    Product Code: HTE FDA class 1 21 CFR 878.4800

    Elevator

    General, Plastic Surgery

    A surgical elevator is a handheld instrument with a flat or angled blade used to lift, separate, or retract tissue from bone or other structures during surgical procedures. It is classified as an FDA Class 1 device under 21 CFR 878.4800, indicating low risk subject to general controls. Product code HTE falls under the General and Plastic Surgery medical specialty.

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    510(k)s
    0
    FEI Numbers
    175
    Registration Numbers
    175
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    HTE
    Device Class
    FDA class 1
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    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 175 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 175 registration numbers. Click on an entry to view related FDA registrations.