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510(k) Data Aggregation

    K Number
    K963642
    Device Name
    INCL II ENDOSCOPE
    Manufacturer
    SOFAMOR DANEK USA,INC.
    Date Cleared
    1998-03-18

    (552 days)

    Product Code
    GWG
    Regulation Number
    882.1480
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The INCLUSIVE® Endoscope is indicated for aiding in the search and removal of nucleus material and for viewing herniated disc material in the lumbar spine via a percutaneous surgical approach. The endoscope is also indicated for visualizing the tissues of the brain and for use in the knee, shoulder, wrist and the temporomandibular joint (TMJ).

    Device Description

    This submission describes an endoscopic system and ancillary equipment. The endoscope consists of light transmitting optical fibers and an image transmitting fiber bundle contained within the scope.

    AI/ML Overview

    I am sorry, but the provided text does not contain information regarding the acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth details.

    The document is a 510(k) summary for the INCLUSIVE® Endoscopic System from 1998, indicating its substantial equivalence to other commercially available arthroscopic and endoscopic systems for its stated indications for use. It primarily focuses on the regulatory approval process rather than a detailed performance study.

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