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

    SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES

    K Number: K953453 · Decision Jan 17, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    57
    Applicant Total
    34
    Review Days
    182

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    Basic Information

    Device Name
    SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES
    K Number
    K953453
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Symbiosis Corp.
    Date Received
    July 19, 1995
    Decision Date
    January 17, 1996
    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

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    Other Clearances by Symbiosis Corp.

    K Number Device Name
    K955119 SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES
    K953242 SYMBIOSIS MONOPLAR ELECTROSURGICAL ELECTRODES
    K952432 SYMBIOSIS BIPOLAR FORCEPS
    K951387 SYMBIOSIS BIPOLAR SCISSORS
    K950286 SYMBIOSIS BIPOLAR SCISSORS
    K946238 SYMBIOSIS GASTROINTESTINAL BIOPSY FORCEPS
    K930773 SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS
    K941426 SYMBIOSIS REUSABLE MONOPOLAR ELECTROSURGICAL PROBE
    K932266 SYMBIOSIS DISPOS GASTRO BIOPSY FORCEPS W/REUSE HAN
    K931957 SYMBIOSIS DISPOSABLE UROLOGICAL BIOPSY FORCEPS
    Search all 34 clearances from Symbiosis Corp. →