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

    VNUS CLOSURE SYSTEM

    K Number: K974521 · Decision Feb 20, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    9
    Review Days
    80

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    Basic Information

    Device Name
    VNUS CLOSURE SYSTEM
    K Number
    K974521
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vnus Medical Technologies, Inc.
    Date Received
    December 2, 1997
    Decision Date
    February 20, 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 Vnus Medical Technologies, Inc.

    K Number Device Name
    K082890 VNUS CLOSUREFAST INTRAVASCULAR CATHETER, MODELS CF7-7-60-2, CF7-7-100-2
    K061373 VNUS CLOSUREFAST CATHETER, MODELS CF7-7-60 AND CF7-7-100
    K052003 VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15); VNUS RFS FLEX, MODEL RFX-6-XX (XX = 10, 20, 30 & 40)
    K040638 VNUS RADIOFREQUENCY GENERATOR, MODEL RFG2
    K033547 VNUS VESSEL AND TISSUE COAGULATION SYSTEM
    K030557 MODIFICATION TO VNUS CLOSURE SYSTEM
    K003092 MODIFICATION TO VNUS CLOSURE SYSTEM
    K982816 VNUS CLOSURE SYSTEM