BEUDAMED
    Product Code: ESI FDA class 3

    Polymer, Natural-Absorbable Gelatin Material

    Unknown

    The natural-absorbable gelatin material polymer is a bioabsorbable material derived from gelatin, intended for use in surgical procedures where a temporary support or hemostatic material that dissolves in tissue is required. It is classified as FDA Class 3, the highest risk category, requiring Premarket Approval (PMA) to demonstrate safety and effectiveness. The product code is ESI, reviewed by the Ear, Nose, Throat panel; no regulation number or formal medical specialty description is on record. No implant or life-sustaining flags apply.

    View on FDA
    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    2
    Years Active
    5

    Basic Information

    Product Code
    ESI
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    EN
    Submission Type
    2

    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
    K954401 GASTROTEC
    K911212 LM-150HT LIGHT SOURCE