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

    ELECTROSURGICAL BASKET ELECTRODES ELECTROSURGICAL BASKET ELECTRODES

    K Number: K981589 · Decision Jul 30, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    10
    Review Days
    87

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    Basic Information

    Device Name
    ELECTROSURGICAL BASKET ELECTRODES ELECTROSURGICAL BASKET ELECTRODES
    K Number
    K981589
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Conway Stuart Medical, Inc.
    Date Received
    May 4, 1998
    Decision Date
    July 30, 1998
    Product Code
    GEI
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by Conway Stuart Medical, Inc.

    K Number Device Name
    K000245 CSM STRETTA SYSTEM
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    K991529 CSM STRETTA CONTROL MODULE ELECTROSURGICAL GENERATOR, MODEL S400
    K990724 CONWAY STUART MODEL 100 IRRIGATION PUMP & ACCESSORIES
    K991291 STRETTA INFLATABLE BASKET CATHETER ELECTRODE WITH ASPIRATION
    K983986 CONWAY STUART MEDICAL MODEL C4 ELECTROSURGICAL GENERATOR
    K983116 ELECTROSURGICAL INFLATABLE BASKET ELECTRODES
    K983415 DELIVERY SHEATH