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510(k) Data Aggregation

    K Number
    K000480
    Device Name
    ACTIVE ELECTRODE MONITORING SYSTEM
    Manufacturer
    ELECTROSCOPE, INC.
    Date Cleared
    2000-05-02

    (78 days)

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

    ELECTROSCOPE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K972562
    Device Name
    BIPOLAR ELECTROSURGICAL PENCIL, STRAIGHT AND ANGLED
    Manufacturer
    ELECTROSCOPE, INC.
    Date Cleared
    1998-01-16

    (191 days)

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

    ELECTROSCOPE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Electroscope, Inc. Bipolar Electrosurgical Pencil is designed as a "Disposable" product. The Bipolar Electrosurgical Pencil is a device designed to be used in procedures involving cutting and coagulation of the soft body tissue.
    Device Description
    The Electroscope, Inc. Bipolar Electrosurgical Pencil is designed as a "Disposable" product. The Bipolar Electrosurgical Pencil is a device designed to be used in procedures involving cutting and coagulation of the soft body tissue.
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    K Number
    K973682
    Device Name
    BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT, BIOPOLAR ARTHROSCOPIC PROBE, ANGLED, BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT,
    Manufacturer
    ELECTROSCOPE, INC.
    Date Cleared
    1997-12-18

    (83 days)

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

    ELECTROSCOPE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bipolar Arthroscopic Probe is an electrosurgical device designed to be used in Arthroscopic procedures involving cutting and coagulation of soft body tissue. The Bipolar Arthroscopic Probe is indicated for use in patients requiring ine bipolar neurossoppf the joint i.e., wrist, knee, shoulder, ankle, and elbow.
    Device Description
    The Bipolar Arthroscopic Probe is an electrosurgical device designed to be used in Arthroscopic procedures involving cutting and coagulation of soft body tissue.
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