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510(k) Data Aggregation

    K Number
    K042132
    Device Name
    NOVASYS TRANSURETHRAL RF SYSTEM
    Manufacturer
    NOVASYS MEDICAL, INC.
    Date Cleared
    2004-12-21

    (134 days)

    Product Code
    NVJ
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVASYS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Novasys Transurethral RF System is indicated for the transurethral treatment of female stress urinary incontinence due to hypermobility in women who have failed conservative treatment and who are not candidates for surgical therapy.
    Device Description
    The Novasys Transurethral RF Generator delivers controlled, low-level radiofrequency energy through the Novasys Transurethral RF Probe for localized collagen denaturation.
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    K Number
    K013730
    Device Name
    ARIEL RADIO FREQUENCY (RF) ELECTROSURGICAL CONTROL MODULE AND ACCESSORIES
    Manufacturer
    NOVASYS MEDICAL, INC.
    Date Cleared
    2002-02-06

    (89 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVASYS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Novasys "Ariel" RF Electrosurgical Control Module and Accessories, in combination with various Novasys electrodes, is indicated for the coagulation of tissue. This device is intended for use by qualified medical personnel trained in the use of electrosurgery.
    Device Description
    Novasys "Ariel" RF Electrosurgical Control Module and Accessories
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    K Number
    K001328
    Device Name
    INTRODUCER SHEATH
    Manufacturer
    NOVASYS MEDICAL, INC.
    Date Cleared
    2000-07-17

    (82 days)

    Product Code
    FEC
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVASYS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001150
    Device Name
    ELECTROSURGICAL ELECTRODE FAMILY, MODEL 20-2 NEEDLE BALLOON CATHETER, MODEL 40-4 NEEDLE BALLOON CATHETER, MODEL 60-6 NEE
    Manufacturer
    NOVASYS MEDICAL, INC.
    Date Cleared
    2000-06-29

    (80 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVASYS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001151
    Device Name
    ELECTROSURGICAL ELECTRODE FAMILY
    Manufacturer
    NOVASYS MEDICAL, INC.
    Date Cleared
    2000-06-27

    (78 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVASYS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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