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

    ELECTRODES/PROBES/DEVICES

    K Number: K974637 · Decision Jan 7, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    57
    Applicant Total
    9
    Review Days
    26

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ELECTRODES/PROBES/DEVICES
    K Number
    K974637
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ximed/Prosure/Injectx
    Date Received
    December 12, 1997
    Decision Date
    January 7, 1998
    Product Code
    FAS
    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
    FAS Electrode, Electrosurgical, Active, Urological

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FAS), ordered by most recent decision date.

    Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc )

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Multi4 System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PLASMA EDGE System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Resection Electrodes with HF cable

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Electrosurgical accessory

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Ximed/Prosure/Injectx

    K Number Device Name
    K002269 ELECTROSURGICAL PROBES AND DEVICES-GELTX
    K994151 PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES
    K983765 INJECTION NEEDLE PROBE/DEVICE-TUNIS
    K983200 INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX
    K981256 ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE
    K974484 ISOLATED ELECTROSURGICAL PROBES AND DEVICES-SALINETRODE
    K962593 ELECTROSURGICAL PROBES & DEVICES
    K945995 BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTS