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510(k) Data Aggregation

    K Number
    K983901
    Device Name
    KSEA HF-SNARE
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    1999-02-01

    (90 days)

    Product Code
    HIH
    Regulation Number
    884.1690
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The KSEA HP-Snare is intended for hysteroscopic use by qualified surgeons or physicians for resection of uterine polyps and tumors.

    Device Description

    The KSEA HF-Snare is a manual reusable surgical devices provided to the end-user in a non-sterile condition. The body contact materials are surgical grade stainless steel.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria for device performance or any studies demonstrating that a device meets such criteria. The document is a 510(k) summary for a medical device (KSEA HF-Snare) and focuses on regulatory aspects like device identification, indications for use, and substantial equivalence to predicate devices, rather than detailed performance studies.

    Therefore, I cannot populate the requested table and sections with information from the given text.

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