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510(k) Data Aggregation

    K Number
    DEN200016
    Device Name
    EndoRotor Device
    Manufacturer
    Interscope, Inc
    Date Cleared
    2020-12-23

    (282 days)

    Product Code
    QNE
    Regulation Number
    876.4330
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    Product Code :

    QNE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EndoRotor device is indicated to resect and remove necrotic tissue in symptomatic Walled off pancreatic necrosis /Walled off necrosis (WOPN/WON) after having undergone endoscopic ultrasound (EUS) guided drainage.
    Device Description
    The EndoRotor ® is a powered resection tool intended to morcellate necrotic pancreatic tissue through the instrument biopsy channel of an endoscope. The device is to be used after a patient has undergone a procedure to drain any fluid accumulated in the pancreas due to pancreatitis.
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