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510(k) Data Aggregation

    K Number
    K243639
    Device Name
    Portare System (FA-001)
    Manufacturer
    Grumpy Innovation, Inc.
    Date Cleared
    2025-06-05

    (192 days)

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

    Grumpy Innovation, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Grumpy Innovation PORTARE System is intended to endoscopic procedures and examination within the nasal lumens and upper airway anatomy. The endoscope is intended to provide visualization via a monitor. The endoscope is intended for use in a hospital or clinical environment. It is intended for use in adults.
    Device Description
    The Grumpy Innovation PORTARE System is a flexible endoscope with steerable navigation and a built-in image and video processing system that wirelessly transmits images and video to a tablet application. The PORTARE System is comprised of a: • Sterile, single-use disposable endoscope handle, steering mechanism, and steerable insertion tube with chip-on-tip camera and LED light source. • Reusable module comprising the primary circuit board with wireless unit and rechargeable battery. • Tablet viewer that runs a software application. The reusable module attaches to the single-use disposable endoscope handle to create a functional endoscope.
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