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510(k) Data Aggregation

    K Number
    K971977
    Device Name
    KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    1997-08-12

    (75 days)

    Product Code
    FBN
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    K023358
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The KSEA 15.5 Fr. Flexible Choledocho-Fiberscope is designed to be used by qualified surgeons and physicians for examination of the gall bladder and bile duct, and, using additional instruments, to perform various diagnostic and therapeutic procedures.

    Device Description

    The KSEA 15.5 Fr. Flexible Choledocho-Fiberscope is a manually operated surgical device. The Flexible Choledocho-Fiberscope is a flexible fiber-optic telescope which utilizes fiber-optic technology. The body contact portions of the Flexible Choledocho-Fiberscope are composed of medical-grade polyurethane. The Accessories are double-action flexible forceps (grasping and biopsy), which are constructed of surgical-grade stainless steel (AISI series 303 and 304 for the shafts, AISI series 420 for jaws and handles).

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for a flexible choledochoscope, focusing on its substantial equivalence to predicate devices, safety, effectiveness, and intended use. It does not include details about device performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement.

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