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510(k) Data Aggregation

    K Number
    K013889
    Device Name
    ENDOSCOPIC MULTI-FIRE CLIP APPLIER
    Manufacturer
    INSCOPE, LLC.
    Date Cleared
    2002-02-07

    (76 days)

    Product Code
    PKL
    Regulation Number
    876.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    INSCOPE, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Endoscopic Multi-fire Clip Applier was designed to be used with an endoscope to place clips in the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis of mucosal and submucosal defects < 3 cm, bleeding ulcers, arteries < 2 mm, polyps < 1.5 cm in diameter, and anchoring to affix jejunal feeding tubes to the wall of the small bowel. The device is not intended for repair of gastrointestinal tract lumenal perforations.
    Device Description
    The InScope Endoscopic Multi-Fire Clip Applier is designed for gastrointestinal endoscopic clipping for marking and hemostasis. It consists of a control handle, an insertion tube, jaws at the distal end for gripping the tissue, and up to 5 clips that can be attached to the tissue individually with each actuation of the device handle. The device is provided sterile and is for one time use only.
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    K Number
    K992477
    Device Name
    ROTOSNARE
    Manufacturer
    INSCOPE, LLC.
    Date Cleared
    1999-08-24

    (29 days)

    Product Code
    FDI
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    INSCOPE, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InScope, LLC rotatable snare is intended for the electrosurgical removal and cauterization of gastrointestinal tract polyps through an endoscope .
    Device Description
    The InScope, LLC rotatable snare consists of an actuation handle, rotation handle and snare loop. The loop is attached to the actuation handle by means of a cable. A monopolar electrical connector is provided on the handle and is electrically connected to the snare loop. The rotation handle is positioned on the snare shaft and provides rotation control of the snare loop to aid in orienting the loop with respect to the polyp. Figure 1, Typical Rotatable Snare, shows several views of the rotatable snare. The InScope, LLC rotatable snares may be used with most monopolar electrosurgical generators. The rotatable snare has a universal connector which is compatible with both Microvasive and Olympus active cord connectors.
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