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510(k) Data Aggregation

    K Number
    K014251
    Device Name
    NTERO HOTROD SYSTEM
    Manufacturer
    NTERO SURGICAL, INC.
    Date Cleared
    2002-03-26

    (90 days)

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

    NTERO SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NTERO HOTROD System is intended to coagulate tissue during surgical procedures.
    Device Description
    Not Found
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    K Number
    K010815
    Device Name
    NTERO NOMAD SYSTEM
    Manufacturer
    NTERO SURGICAL, INC.
    Date Cleared
    2001-06-15

    (88 days)

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

    NTERO SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K992572
    Device Name
    NTERO RF SLEEVE
    Manufacturer
    NTERO SURGICAL, INC.
    Date Cleared
    1999-09-24

    (53 days)

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

    NTERO SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NTERO RF Sleeve is intended for use during laparoscopic surgery to maintain a port of entry and to coagulate tissue.
    Device Description
    Not Found
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