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510(k) Data Aggregation

    K Number
    K971374
    Device Name
    GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE
    Manufacturer
    WILSON GREATBATCH TECHNOLOGIES, INC.
    Date Cleared
    1998-05-13

    (394 days)

    Product Code
    HIH
    Regulation Number
    884.1690
    Why did this record match?
    Applicant Name (Manufacturer) :

    WILSON GREATBATCH TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Greatbatch Scientific MR Compatible Hysteroscope is used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
    Device Description
    The Greatbatch Scientific MR Compatible Hysteroscopes are available in standard and autoclavable 2.0mm and 4.0mm outer diameters with 0° and 30° viewing angles.
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    K Number
    K971377
    Device Name
    GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE
    Manufacturer
    WILSON GREATBATCH TECHNOLOGIES, INC.
    Date Cleared
    1998-04-30

    (381 days)

    Product Code
    CCW
    Regulation Number
    868.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    WILSON GREATBATCH TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Greatbatch Scientific MR Compatible Laryngoscope is intended for use in endoscopic visualization and surgery on the trachea, pharynx and larynx in a MR or an interventional MR environment, not to exceed a shielded 1.5 Tesla magnet.
    Device Description
    The Greatbatch Scientific MR Compatible Laryngoscope is available in standard and autoclavable 8.0mm, 70° angle.
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    K Number
    K972280
    Device Name
    GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES
    Manufacturer
    WILSON GREATBATCH TECHNOLOGIES, INC.
    Date Cleared
    1997-12-11

    (176 days)

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

    WILSON GREATBATCH TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use to permit direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures in a MR or an interventional MR environment, not to exceed a 1.5 Tesla static magnetic field.
    Device Description
    The Greatbatch Scientific MR Compatible Laparoscope and Operating Laparoscopes are available in standard and autoclavable 8.0mm, 10.0mm sizes, with 0°, 30° or 45° angles.
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    K Number
    K971781
    Device Name
    GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES
    Manufacturer
    WILSON GREATBATCH TECHNOLOGIES, INC.
    Date Cleared
    1997-11-21

    (191 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    WILSON GREATBATCH TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Greatbatch Scientific MR Compatible Arthroscopes and Small Joint Arthroscopes and Accessories are intended for use by practioners to treat the small joints of the wrist, knee, ankles, elbow, shoulder, and the temporal- mandibular joint of patients in a MR or an interventional MR environment, not to exceed a shielded 1.5 Tesla magnet.
    Device Description
    The Greatbatch Scientific MR Compatible Arthroscopes and Small Joint Arthroscopes are available in standard and autoclavable 1.7mm, 2.7mm and 4.0mm sizes, with 0°, 30° or 70° angles.
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    K Number
    K970619
    Device Name
    GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE
    Manufacturer
    WILSON GREATBATCH TECHNOLOGIES, INC.
    Date Cleared
    1997-11-19

    (274 days)

    Product Code
    CCW
    Regulation Number
    868.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    WILSON GREATBATCH TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Greatbatch Scicntific MR Fiber Optic Laryngoscope Handle when used with a green color marking blade system, is intended to facilitate and aid in tracheal . - intubation in a Magnetic Resonance Imaging (MRI) or an interventional Magnetic Resonance (MR) environment, not to exceed a 1.5 Tesla static magnet field.
    Device Description
    The MR Fiber Optic Intubating Laryngoscope consists of a handle which is manufactured from brass and is chrome plated. The cell used to provide the light source energy is a proprietary "c" size cell.
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    K Number
    K971375
    Device Name
    GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE
    Manufacturer
    WILSON GREATBATCH TECHNOLOGIES, INC.
    Date Cleared
    1997-10-31

    (200 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    WILSON GREATBATCH TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Greatbatch Scientific MR Compatible Sinuscope is intended for use in sinus endoscopy surgery in a MR or an interventional MR environment, not to exceed a shielded 1.5 Tesla magnet.
    Device Description
    The Greatbatch Scientific MR Compatible Sinuscope is available in standard and autoclavable 2.7mm and 4.0mm sizes, with 0°, 30° or 70° angles.
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