BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    Theracor

    K Number: K253339 · Decision Dec 22, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    134
    Registration Numbers
    134
    Same Product Code
    187
    Applicant Total
    3
    Review Days
    83

    Basic Information

    Device Name
    Theracor
    K Number
    K253339
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stimlabs, LLC
    Date Received
    September 30, 2025
    Decision Date
    December 22, 2025
    Product Code
    KGN
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KGN Wound Dressing With Animal-Derived Material(S)

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    Other Clearances by Stimlabs, LLC

    K Number Device Name
    K242828 Corplex P/ Theracor P/ Allacor P
    K231325 Corplex P / Theracor P / Allacor P