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510(k) Data Aggregation

    K Number
    K962396
    Device Name
    KSEA BIPOLAR GOAGULATING FORCEPS
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    1996-08-27

    (67 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    KSEA BIPOLAR GOAGULATING FORCEPS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The KSEA Bipolar Coagulating Forceps for endoscopic and non-endoscopic ENT surgery are designed to be used with high frequency electrical current to coagulate tissue during endoscopic and non-endoscopic ENT surgical procedures.

    Device Description

    The KSEA Bipolar Coagulating Forceps are manual reusable surgical devices. The KSEA Bipolar Coagulating Forceps are long enough to gain access to the surgical area and are designed to be used as accessories to endoscopes. The body contact material is surgical grade stainless steel. The Bipolar Coagulating Forceps are insulated with commonly used materials.

    AI/ML Overview

    This document is a 510(k) summary for a medical device (KSEA Bipolar Coagulating Forceps), not a study report describing acceptance criteria and device performance evaluation based on clinical data.

    Therefore, I cannot provide the requested information, which typically pertains to the evaluation of AI/ML-driven devices or diagnostic tools. The content provided describes a surgical instrument and focuses on its design, intended use, and substantial equivalence to predicate devices, rather than a performance study with acceptance criteria.

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