Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K191324
    Device Name
    CivaDerm
    Manufacturer
    CivaTech Oncology Inc.
    Date Cleared
    2019-09-20

    (127 days)

    Product Code
    KXK, ONL
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    CivaTech Oncology Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CivaDerm™ Pd103 indicated for treatment of temporary intraoperative or surface application to treat selected localized tumors. It can be used either as primary treatment for residual disease after excision of primary or recurrent tumors. This brachytherapy source may be used concurrently with or following treatment with other interventions, such as external beam therapy.
    Device Description
    The CivaDerm utilizes biocompatible materials and bioabsorbable polymers to encapsulate Pd-103, a radionuclide with a long history in radiotherapy. CivaDerm is a planar unidirectional source intended to deliver x-ray radiation for surface brachytherapy procedures. By utilizing gold backing with the radionuclide. CivaDerm provides radiation in one direction. This allows it to target radiation dose to a contoured exterior surface without irradiating surrounding healthy tissue.
    Ask a Question

    Page 1 of 1