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

    INJECTION NEEDLE PROBE/DEVICE-TUNIS

    K Number: K983765 · Decision Dec 11, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    88
    Applicant Total
    9
    Review Days
    46

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    Basic Information

    Device Name
    INJECTION NEEDLE PROBE/DEVICE-TUNIS
    K Number
    K983765
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ximed/Prosure/Injectx
    Date Received
    October 26, 1998
    Decision Date
    December 11, 1998
    Product Code
    FBK
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FBK Endoscopic Injection Needle, Gastroenterology-Urology

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    Other Clearances by Ximed/Prosure/Injectx

    K Number Device Name
    K002269 ELECTROSURGICAL PROBES AND DEVICES-GELTX
    K994151 PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES
    K983200 INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX
    K981256 ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE
    K974484 ISOLATED ELECTROSURGICAL PROBES AND DEVICES-SALINETRODE
    K974637 ELECTRODES/PROBES/DEVICES
    K962593 ELECTROSURGICAL PROBES & DEVICES
    K945995 BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTS