BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Pro-Tx Endorectal Balloon (PROT-25)

    K Number: K223249 · Decision Feb 10, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    151

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    Basic Information

    Device Name
    Pro-Tx Endorectal Balloon (PROT-25)
    K Number
    K223249
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    892.5720
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dxtx Medical, Inc.
    Date Received
    September 12, 2022
    Decision Date
    February 10, 2023
    Product Code
    PCT
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PCT Prostate Immobilizer Rectal Balloon

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