BEUDAMED
    Product Code: ESF FDA class 2 21 CFR 878.3500

    Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent

    General, Plastic Surgery

    The composite synthetic PTFE with carbon-fiber ENT polymer is a structural implant material used in ear, nose, and throat reconstructive procedures, leveraging the mechanical properties of polytetrafluoroethylene combined with carbon fiber reinforcement. It is classified as FDA Class 2, representing moderate risk, and requires 510(k) premarket clearance. The product code is ESF, regulated under 21 CFR 878.3500 in the General, Plastic Surgery specialty. This device is designated as an implant.

    View on FDA
    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    2
    Years Active
    7

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    Basic Information

    Product Code
    ESF
    Device Class
    FDA class 2
    Regulation Number
    878.3500
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    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
    K891247 BEHIND-THE-EAR HEARING AID MODEL 404 PP-PC
    K813224 CERAVITAL CERAMIC EAR CANAL WALL PROSTH