BEUDAMED
    Product Code: EPW FDA class 1 21 CFR 878.4950

    Support, Head, Surgical, Ent

    General, Plastic Surgery

    The ENT surgical head support is a positioning device used during ear, nose, and throat surgical procedures to stabilize and correctly orient the patient's head, enabling safe and precise surgical access. It is classified as FDA Class 1, requiring only general controls and no premarket submission. The product code is EPW, regulated under 21 CFR 878.4950 in the General, Plastic Surgery specialty. No implant, life-sustaining, GMP-exempt, or third-party review designations apply.

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    510(k)s
    2
    FEI Numbers
    10
    Registration Numbers
    10
    Unique Applicants
    2
    Years Active
    2

    Basic Information

    Product Code
    EPW
    Device Class
    FDA class 1
    Regulation Number
    878.4950
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    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
    K821306 HEAD-UP SUPINE SAFETY SUPPORT CUSHION
    K801326 ANSPACH OPERATING TABLE SUPPORT/SPINAL

    FEI Numbers

    This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.